Events

Rappel de Qube Compact Monitor Model 91390

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Spacelabs Healthcare, Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63504
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0403-2013
  • Date de mise en oeuvre de l'événement
    2012-10-19
  • Date de publication de l'événement
    2012-11-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114077
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    Spacelabs healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. the monitor will function normally until the batteries become depleted and then the monitor will shut down. in addition the monitor may fail to turn on due to an internal short.
  • Action
    Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated October 19, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact Spacelabs Healthcare at 1-800522-7025 option 2 for questions regarding this notice.

Device

Qube Compact Monitor Model 91390
  • Modèle / numéro de série
    Serial numbers for devices distributed in the US:  1390-000102, 1390-000103, 1390-000104, 1390-000105, 1390-000106, 1390-000107, 1390-000108, 1390-000109, 1390-000110, 1390-000111, 1390-000112, 1390-000113, 1390-000114, 1390-000115, 1390-000116, 1390-000119, 1390-000120, 1390-000150, 1390-000151, 1390-000152, 1390-000153, 1390-000154, 1390-000155, 1390-000156, 1390-000157, 1390-000158, 1390-000159, 1390-000160, 1390-000161, 1390-000162, 1390-000163, 1390-000164, 1390-000165, 1390-000166, 1390-000167, 1390-000168, 1390-000169, 1390-000170, 1390-000171, 1390-000172, 1390-000173, 1390-000174, 1390-000175, 1390-000176, 1390-000177, 1390-000178, 1390-000179, 1390-000180, 1390-000181, 1390-000182, 1390-000183, 1390-000184, 1390-000185, 1390-000186, 1390-000187, 1390-000188, 1390-000189, 1390-000190, 1390-000191, 1390-000192, 1390-000193, 1390-000195, 1390-000196, 1390-000197, 1390-000198, 1390-000199, 1390-000200, 1390-000201, 1390-000202, 1390-000203, 1390-000204, 1390-000205, 1390-000206, 1390-000207, 1390-000208, 1390-000209, 1390-000210, 1390-000211, 1390-000212, 1390-000213, 1390-000214, 1390-000215, 1390-000216, 1390-000217, 1390-000218, 1390-000219, 1390-000220, 1390-000221, 1390-000222, 1390-000223, 1390-000224, 1390-000225, 1390-000226, 1390-000227, 1390-000228, 1390-000229, 1390-000230, 1390-000231, 1390-000232, 1390-000233, 1390-000234, 1390-000235, 1390-000236, 1390-000237, 1390-000238, 1390-000239, 1390-000240, 1390-000241, 1390-000242, 1390-000243, 1390-000244, 1390-000245, 1390-000246, 1390-000247, 1390-000248, 1390-000249, 1390-000250, 1390-000251, 1390-000252, 1390-000253, 1390-000254, 1390-000255, 1390-000256, 1390-000257, 1390-000258, 1390-000259, 1390-000260, 1390-000261, 1390-000262, 1390-000263, 1390-000264, 1390-000266, 1390-000267, 1390-000268, 1390-000269, 1390-000270, 1390-000271, 1390-000272, 1390-000273, 1390-000274, 1390-000275, 1390-000276, 1390-000277, 1390-000278, 1390-000279, 1390-000280, 1390-000281, 1390-000282, 1390-000283, 1390-000284, 1390-000285, 1390-000286, 1390-000287, 1390-000288, 1390-000289, 1390-000296, 1390-000297, 1390-000298, 1390-000299, 1390-000300, 1390-000301, 1390-000302, 1390-000304, 1390-000305, 1390-000307, 1390-000308, 1390-000310, 1390-000311, 1390-000312, 1390-000314, 1390-000315, 1390-000316, 1390-000317, 1390-000318, 1390-000319, 1390-000321, 1390-000322, 1390-000323, 1390-000325, 1390-000341, 1390-000342, 1390-000343, 1390-000344, 1390-000345, 1390-000346, 1390-000347, 1390-000348, 1390-000349, 1390-000350, 1390-000351, 1390-000352, 1390-000353, 1390-000354, 1390-000355, 1390-000356, 1390-000357, 1390-000358, 1390-000359, 1390-000360, 1390-000361, 1390-000362, 1390-000363, 1390-000364, 1390-000365, 1390-000366, 1390-000367, 1390-000368, 1390-000369, 1390-000370, 1390-000371, 1390-000372, 1390-000373, 1390-000374, 1390-000375, 1390-000376, 1390-000377, 1390-000378, 1390-000379, 1390-000380, 1390-000381, 1390-000382, 1390-000383, 1390-000384, 1390-000385, 1390-000386, 1390-000387, 1390-000388, 1390-000389, 1390-000390, 1390-000391, 1390-000392, 1390-000393, 1390-000394, 1390-000420, 1390-000421, 1390-000422, 1390-000423, 1390-000424, 1390-000425, 1390-000426, 1390-000427, 1390-000428, 1390-000429, 1390-000430, 1390-000431, 1390-000432, 1390-000433, 1390-000434, 1390-000435, 1390-000436, 1390-000437, 1390-000438, 1390-000439, 1390-000440, 1390-000441, 1390-000442, 1390-000443, 1390-000444, 1390-000445, 1390-000446, 1390-000447, 1390-000448, 1390-000449, 1390-000450, 1390-000451, 1390-000452, 1390-000453, 1390-000454, 1390-000455, 1390-000456, 1390-000457, 1390-000458, 1390-000459, 1390-000460, 1390-000461, 1390-000462, 1390-000463, 1390-000464, 1390-000465, 1390-000467, 1390-000468, 1390-000469, 1390-000470, 1390-000483, 1390-000564, 1390-000582, 1390-000583, 1390-000584, 1390-000585, 1390-000586, 1390-000587, 1390-000588, 1390-000589, 1390-000590, 1390-000591, 1390-000592, 1390-000593, 1390-000594, 1390-000595, 1390-000597, 1390-000598, 1390-000599, 1390-000600, 1390-000601, 1390-000602, 1390-000603, 1390-000606, 1390-000614, 1390-000615, 1390-000616, 1390-000623, 1390-000624, 1390-000625, 1390-000626, 1390-000627, 1390-000628, 1390-000629, 1390-000630, 1390-000631, 1390-000632, 1390-000633, 1390-000634, 1390-000635, 1390-000636, 1390-000637, 1390-000638, 1390-000639, 1390-000640, 1390-000641, 1390-000642, 1390-000643, 1390-000644, 1390-000645, 1390-000646, 1390-000647, 1390-000648, 1390-000649, 1390-000650, 1390-000651, 1390-000652, 1390-000653, 1390-000654, 1390-000655, 1390-000656, 1390-000657, 1390-000658, 1390-000659, 1390-000660, 1390-000661, 1390-000662, 1390-000663, 1390-000664, 1390-000665, 1390-000666, 1390-000667, 1390-000668, 1390-000669, 1390-000670, 1390-000671, 1390-000672, 1390-000673, 1390-000674, 1390-000675, 1390-000676, 1390-000677, 1390-000678, 1390-000679, 1390-000680, 1390-000681, 1390-000682, 1390-000683, 1390-000684, 1390-000685, 1390-000686, 1390-000687, 1390-000688, 1390-000698, 1390-000699, 1390-000700, 1390-000701, 1390-000702, 1390-000703, 1390-000704, 1390-000705, 1390-000706, 1390-000707, 1390-000708, 1390-000710, 1390-000712, 1390-000713, 1390-000714, 1390-000720, 1390-000721, 1390-000728, 1390-000729, 1390-000730, 1390-000731, 1390-000732, 1390-000733, 1390-000734, 1390-000735, 1390-000736, 1390-000737, 1390-000738, 1390-000742, 1390-000743, 1390-000744, 1390-000745, 1390-000746, 1390-000747, 1390-000748, 1390-000749, 1390-000750, 1390-000751, 1390-000752, 1390-000753, 1390-000754, 1390-000755, 1390-000756, 1390-000757, 1390-000758, 1390-000759, 1390-000760, 1390-000761, 1390-000762, 1390-000763, 1390-000764, 1390-000765, 1390-000766, 1390-000767, 1390-000768, 1390-000769, 1390-000775, 1390-000776, 1390-000777, 1390-000778, 1390-000779, 1390-000780, 1390-000781, 1390-000782, 1390-000792, 1390-000793, 1390-000794, 1390-000795, 1390-000796, 1390-000800, 1390-000801, 1390-000802, 1390-000803, 1390-000804, 1390-000805, 1390-000806, 1390-000807, 1390-000808, 1390-000809, 1390-000810, 1390-000811, 1390-000812, 1390-000813, 1390-000814, 1390-000815, 1390-000816, 1390-000817, 1390-000818, 1390-000819, 1390-000820, 1390-000821, 1390-000822, 1390-000823, 1390-000824, 1390-000825, 1390-000826, 1390-000827, 1390-000828, 1390-000829, 1390-000830, 1390-000831, 1390-000832, 1390-000833, 1390-000834, 1390-000835, 1390-000836, 1390-000837, 1390-000838, 1390-000839, 1390-000840, 1390-000841, 1390-000842, 1390-000843, 1390-000844, 1390-000845, 1390-000846, 1390-000847, 1390-000848, 1390-000849, 1390-000850, 1390-000851, 1390-000852, 1390-000853, 1390-000854, 1390-000855, 1390-000856, 1390-000857, 1390-000858, 1390-000859, 1390-000860, 1390-000861, 1390-000862, 1390-000863, 1390-000870, 1390-000871, 1390-000872, 1390-000887, 1390-000888, 1390-000889, 1390-000890, 1390-000891, 1390-000892, 1390-000893, 1390-000894, 1390-000895, 1390-000896, 1390-000897, 1390-000898, 1390-000899, 1390-000900, 1390-000901, 1390-000902, 1390-000903, and 1390-000904.   Serial numbers for devices distributed INTERNATIONAL: On 4/16/13 the firm advised FDA that they added serial number 1390-000055 and 1390-000913.  1390-000290, 1390-000291, 1390-000337, 1390-000338, 1390-000339, 1390-000340, 1390-000607, 1390-000608, 1390-000609, 1390-000610, 1390-000689, 1390-000690, 1390-000691, 1390-000692, 1390-000693, 1390-000695, 1390-000536, 1390-000537, 1390-000709, 1390-000722, 1390-000723, 1390-000724, 1390-000725, 1390-000879, 1390-000880, 1390-000881, 1390-000905, 1390-000906, 1390-000907, 1390-000908, 1390-000909, 1390-000910 1390-000009, 1390-000010, 1390-000011, 1390-000012, 1390-000013, 1390-000014, 1390-000015, 1390-000016, 1390-000017, 1390-000018, 1390-000046, 1390-000048, 1390-000049, 1390-000051, 1390-000052, 1390-000053, 1390-000056, 1390-000057, 1390-000059, 1390-000060, 1390-000061, 1390-000062, 1390-000063, 1390-000101, 1390-000117, 1390-000118, 1390-000125, 1390-000127, 1390-000128, 1390-000138, 1390-000139, 1390-000140, 1390-000141, 1390-000142, 1390-000143, 1390-000144, 1390-000145, 1390-000146, 1390-000147, 1390-000148, 1390-000149, 1390-000326, 1390-000327, 1390-000328, 1390-000329, 1390-000330, 1390-000331, 1390-000332, 1390-000333, 1390-000334, 1390-000335, 1390-000336, 1390-000466, 1390-000535, 1390-000552, 1390-000568, 1390-000605, 1390-000611, 1390-000612, 1390-000613, 1390-000715, 1390-000716, 1390-000739, 1390-000740, 1390-000741, 1390-000770, 1390-000787, 1390-000788, 1390-000789, 1390-000790, 1390-000791, 1390-000797, 1390-000798, 1390-000876, 1390-000877, 1390-000878, 1390-1390-000047, 1390-00002, 1390-000618, 1390-000619, 1390-000620, 1390-000621, 1390-000622, 1390-000509, 1390-000510, 1390-000511, 1390-000512, 1390-000513, 1390-000514, 1390-000553, 1390-000554, 1390-000121, 1390-000524, 1390-000771, 1390-000772, 1390-000292, 1390-000293, 1390-000294, 1390-000295, 1390-000911, 1390-000555, 1390-000556, 1390-000557, 1390-000558, 1390-000559, 1390-000560, 1390-000561, 1390-000562, 1390-000563, 1390-000565, 1390-000566, 1390-000567, 1390-000569, 1390-000570, 1390-000571, 1390-000572, 1390-000573, 1390-000574, 1390-000575, 1390-000576, 1390-000577, 1390-000578, 1390-000579, 1390-000580, 1390-000581 1390-000395, 1390-000396, 1390-000397, 1390-000398, 1390-000399, 1390-000400, 1390-000401, 1390-000402, 1390-000403, 1390-000404, 1390-000405, 1390-000406, 1390-000407, 1390-000408, 1390-000409, 1390-000410, 1390-000411, 1390-000412, 1390-000413, 1390-000414, 1390-000415, 1390-000416, 1390-000417, 1390-000418, 1390-000419, 1390-000604, 1390-000130, 1390-000131, 1390-000132, 1390-000133, 1390-000135, 1390-000136, 1390-000137, 1390-000493, 1390-000496, 1390-000497, 1390-000498, 1390-000499, 1390-000500, 1390-000501, 1390-000502, 1390-000525, 1390-000526, 1390-000527, 1390-000528, 1390-000529, 1390-000530, 1390-000531, 1390-000532, 1390-000533, 1390-000534, 1390-000596, 1390-000617, 1390-000799, and 1390-000696.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.On 4/16/13 the firm advised FDA that they added serial number 1390-000055 and 1390-000913. The two additional serial numbers were added because they were provided as replacements to a French customer whose devices had been returned to support the firm's investigation. The customer had already received the Urgent Medical Device correction, customer letter and required Spacelabs to provide these devices with the understanding that they would require the field corrective action
  • Description du dispositif
    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. || The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Adresse du fabricant
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Société-mère du fabricant (2017)
    OSI Systems Inc
  • Source
    USFDA