Events

Rappel de Spacelabs Medical Vital Signs Monitor, Model 91220

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, Incorporated.

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
    55319
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3185-2011
  • Date de mise en oeuvre de l'événement
    2010-04-14
  • Date de publication de l'événement
    2011-09-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90548
  • 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 MHZ
  • Cause
    There have been reports that the spacelabs medical vital signs monitor, model 91220, will not power up with ac power and will no longer charge the batteries.
  • Action
    SpaceLabs Healthcare sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 15, 2010, to all affected customers. International consignees were notified by e-mail on April 22, 2010, with the customer notification letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to weigh the benefits versus the risks when deciding whether or not to continue to use the device until their monitors can be upgraded. Customers were asked to brief their staff about the possibility of the monitor failure to help prevent an adverse event from happening.

Device

Spacelabs Medical Vital Signs Monitor, Model 91220
  • Modèle / numéro de série
    SERIAL NUMBERS: 1220M000275, 1220M000538, 1220M000552, 1220M000781, 1220M000902, 1220M000908, 1220M000910, 1220M000915, 1220M000917, 1220M000918, 1220M000919, 1220M000923, 1220M000925, 1220M000927, 1220M000928, 1220M000929, 1220M000930, 1220M000931, 1220M000932, 1220M000934, 1220M000935, 1220M000937, 1220M000938, 1220M000940, 1220M000941, 1220M000943, 1220M000944, 1220M000945, 1220M000947, 1220M000949, 1220M000950, 1220M000952, 1220M000953, 1220M000954, 1220M000955, 1220M000956, 1220M000957, 1220M000958, 1220M000959, 1220M000960, 1220M000962, 1220M000963, 1220M000964, 1220M000966, 1220M000968, 1220M000971, 1220M000972, 1220M000973, 1220M000974, 1220M000975, 1220M000977, 1220M000979, 1220M000980, 1220M000981, 1220M000982, 1220M000984, 1220M000985, 1220M000995, 1220M000996, 1220M000997, 1220M000999, 1220M001000, 1220M001001, 1220M001002, 1220M001003, 1220M001004, 1220M001005, 1220M001006, 1220M001007, 1220M001008, 1220M001009, 1220M001010, 1220M001013, 1220M001014, 1220M001015, 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1220M001518, 1220M001519, 1220M001520, 1220M001521, 1220M001522, 1220M001523, 1220M001524, 1220M001525, 1220M001526, 1220M001527, 1220M001528, 1220M001529, 1220M001530, 1220M001531, 1220M001532, 1220M001533, 1220M001534, 1220M001535, 1220M001536, 1220M001537, 1220M001538, 1220M001539, 1220M001540, 1220M001543, 1220M001544, 1220M001545, 1220M001546, 1220M001547, 1220M001548, 1220M001549, 1220M001550, 1220M001551, 1220M001552, 1220M001553, 1220M001554, 1220M001555, 1220M001556, 1220M001557, 1220M001558, 1220M001559, 1220M001560, 1220M001561, 1220M001562, 1220M001563, 1220M001564, 1220M001565, 1220M001566, 1220M001567, 1220M001568, 1220M001569, 1220M001570, 1220M001571, 1220M001572, 1220M001573, 1220M001574, 1220M001575, 1220M001576, 1220M001578, 1220M001579, 1220M001580, 1220M001581, 1220M001582, 1220M001583, 1220M001584, 1220M001585, 1220M001586, 1220M001587, 1220M001588, 1220M001589, 1220M001590, 1220M001591, 1220M001592, 1220M001593, 1220M001594, 1220M001595, 1220M001596, 1220M001597, 1220M001598, 1220M001599, 1220M001600, 1220M001601, 1220M001602, 1220M001603, 1220M001604, 1220M001605, 1220M001606, 1220M001607, 1220M001608, 1220M001609, 1220M001610, 1220M001611, 1220M001612, 1220M001613, 1220M001614, 1220M001615, 1220M001616, 1220M001617, 1220M001618, 1220M001619, 1220M001620, 1220M001621, 1220M001622, 1220M001623, 1220M001624, 1220M001625, 1220M001626, 1220M001627, 1220M001628, 1220M001629, 1220M001630, 1220M001631, 1220M001632, 1220M001633, 1220M001634, 1220M001635, 1220M001636, 1220M001637, 1220M001638, 1220M001639, 1220M001640, 1220M001641, 1220M001642, 1220M001643, 1220M001644, 1220M001645, 1220M001646, 1220M001647, 1220M001648, 1220M001649, 1220M001650, 1220M001651, 1220M001652, 1220M001653, 1220M001654, 1220M001655, 1220M001656, 1220M001658, 1220M001659, 1220M001660, 1220M001719, 1220M001720, 1220M001721, 1220M001722, 1220M001723, 1220M001724, 1220M001725, 1220M001726, 1220M001727, 1220M001728, 1220M001729, 1220M001730, 1220M001731, 1220M001732, and 1220M001742.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of UNITED ARAB EMIRATES, ARGENTINA, AUSTRALIA, BELGIUM, BAHRAIN, BRAZIL, CANADA, CHINA, COLOMBIA, GERMANY, ECUADOR, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, JORDAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, MALAYSIA, OMAN, POLAND, PUERTO RICO, PARAGUAY, ROMANIA, SAUDI ARABIA, SINGAPORE, SYRIAN ARAB REPUBLIC, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and URUGUAY.
  • Description du dispositif
    The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. || The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • Adresse du fabricant
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA