Events

Rappel de LIFEPAK 20 Defibrillator/monitor

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 Medtronic Emergency Response Systems, Inc..

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
    37864
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0925-2007
  • Date de mise en oeuvre de l'événement
    2007-04-27
  • Date de publication de l'événement
    2007-06-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51986
  • 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
    Defibrillator/monitor - Product Code MJK
  • Cause
    White screen lock up: lifepak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. this may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.
  • Action
    On 04/27/2007 firm sent letters via return receipt to all domestic and foreign customers. The letter recommends for customers to turn the defibrillator power off and back on to restore normal operation in the event of a white screen condition. In addition, the letter advises that a representative from the firm will contact customer to make arrangements to provide a software upgrade to correct the issue.

Device

LIFEPAK 20 Defibrillator/monitor
  • Modèle / numéro de série
    Affected Part Numbers: 3202487-073 through -083; 3202487-087 through -090; 3202487-092; 3202487-093; 3202487-098; 3202488-036; 3202488-038 through -042; 3202488-045; 3202488-046; and 3202488-050. LP 20 defibrillator serial numbers: DOMESTIC 35246397, 35222145, 35222147, 35222171, 35246407, 35195082, 35202031, 35202041, 35213722, 35213784, 35216799, 35216801, 35219423, 35219450, 35213803, 35213807, 35216785, 35216786, 35216791, 35216793, 35216797, 35219435, 35219444, 35219446, 35219447, 35219448, 35219451, 35219452, 35219463, 35219464, 35219465, 35219467, 35219469, 35222141, 35232801, 35237779, 35237782, 35237784, 35237785, 35237786, 35237788, 35237789, 35237792, 35237793, 35237794, 35237800, 35237802, 35237803, 35239818, 35222169, 35232448, 35232925, 35233140, 35195289, 35213796, 35216787, 35219445, 35216794, 35216795, 35219441, 35219457, 35219459, 35232449, 35213805, 35216784, 35216788, 35219453, 35219454, 35219461, 35150433, 35150435, 35154911, 35158493, 35158499, 35161156, 35161163, 35161242, 35161244, 35161247, 35161249, 35161251, 35161252, 35161253, 35161255, 35161257, 35161258, 35161259, 35161260, 35161262, 35161263, 35161264, 35161267, 35161268, 35161269, 35161270, 35161271, 35161272, 35161273, 35161274, 35161275, 35161276, 35161278, 35161280, 35161281, 35161282, 35161283, 35161286, 35161291, 35166342, 35166344, 35166346, 35166351, 35166354, 35166355, 35166356, 35166357, 35166359, 35166363, 35166365, 35166367, 35166371, 35166372, 35166375, 35166377, 35166381, 35166385, 35166386, 35152846, 35152854, 35150429, 35150431, 35152839, 35152862, 35154877, 35154882, 35154908, 35158482, 35226477, 35226479, 35226482, 35226483, 35226484, 35226487, 35226489, 35226492, 35226493, 35226494, 35226496, 35226498, 35226499, 35226502, 35226515, 35226516, 35233136, 35233149, 35233154, 35233153, 35152851, 35152860, 35047103, 35065639, 35065640, 35065644, 35065649, 35065652, 35065655, 35088936, 35150422, 35150424, 35151610, 35151613, 35151615, 35152861, 35154873, 35154876, 35154883, 35154888, 35152847, 35152853, 35043904, 35084040, 35088934, 35150408, 35150414, 35151616, 35152845, 35154890, 35161171, 35161261, 35161265, 35161288, 35166347, 35166352, 35166353, 35166360, 35166364, 35166366, 35166368, 35166369, 35166370, 35166373, 35166374, 35166376, 35166378, 35166379, 35166380, 35166382, 35172605, 35172611, 35172613, 35226504, 35226510, 35226481, 35233138, 35226500, 35226506, 35226519, 35226520, 35226526, 35244234, 35213806, 35219432, 35219440, 35219442, 35244337, 35226486, 35226497, 35233137, 35245167, 35226518, 35202048, 35219443, 35222137, 35219472, 35222146, 35222153, 35222168, 35219449, 35246388, 35233122, 35233144, 35232447, 35166358, 35222142, 35219456, 35239851, 35158490, 35166361, 35161254, 35226505, 35226509, 35226513, 35226521, 35226524, 35226525, 35233120, 35233123, 35233125, 35233127, 35233129, 35233131, 35233132, 35233134, 35233135, 35233139, 35233141, 35233143, 35233148, 35233150, 35233155, 35233158, 30778465, 31004425, 35233110, 35233142, 35202046, 35213791, 35219458, 35222138, 35222150, 35222156, 35222167, 35222170, 35233116, 35233145, 35233147, 35233152, 35233126, 35213732, 35216789, 35219434, 35232452, 35232810, 35233099, 35233102, 35226378, 35226508, 35233117, 35213790, 35233115, 35233151, 35213801, 35213808, 35213809, 35213810, 35216780, 35219462, 35219466, 35219468, 35219470, 35222139, 35222151, 35222157, 35222163, 35226164, 35226165, 35226166, 35226167, 35226169, 35226170, 35232443, 35232450, 35232806, 35232809, 35232910, 35232915, 35232928, 35232931, 35233090, 35233092, 35233101, 35233103, 35233104, 35233108, 35233109, 35237791, 35065654, 35233133, 35244348, 35245143, 35245162, 35245165, 35246386, 35246391, 35246394, 35246396, 35246399, 35246402, 35246416, 35246420, 35246421, 35246422, 35246423, 35246425, 35246430, 35246431, 35246432, 35246433, 35249248, 35249255, 35222140, 35226490, 35226491, 35233156, 35232442, 35232451, 35219471, 35233128, 35222148, 35222165, 35246393, 35246417, 35246426, 35249256, 35249264, 35250340, 35250349, 35250352, 35250354, 35246406, 35246408, 35187570, 35187729, 35187733, 35187740, 35187745, 35187750, 35187753, 35187754, 35192461, 35192465, 35192467, 35192474, 35192475, 35192488, 35192492, 35192494, 35195062, 35195069, 35195073, 35195074, 35195075, 35195077, 35195085, 35195086, 35195240, 35195243, 35195245, 35195246, 35195247, 35195248, 35195249, 35195250, 35195251, 35195252, 35195253, 35195254, 35195255, 35195256, 35195257, 35195258, 35195259, 35195260, 35195261, 35195262, 35195263, 35195264, 35195265, 35195266, 35195267, 35195269, 35195270, 35195271, 35195272, 35195273, 35195274, 35195276, 35195277, 35195279, 35195280, 35195282, 35195283, 35195284, 35195285, 35195286, 35195287, 35195288, 35200196, 35200197, 35200198, 35202024, 35202025, 35202026, 35202027, 35202032, 35202033, 35202042, 35202043, 35202044, 35202045, 35202047, 35202049, 35202050, 35213720, 35213723, 35213724, 35213726, 35213728, 35213730, 35213781, 35213782, 35213783, 35213785, 35213786, 35213788, 35213789, 35213792, 35213793, 35213797, 35213798, 35213799, 35213800, 35213802, 35216776, 35216777, 35216778, 35216779, 35216781, 35216790, 35216792, 35216796, 35216802, 35216803, 35216807, 35216808, 35216809, 35216811, 35216812, 35216814, 35216815, 35216816, 35219424, 35219425, 35219426, 35219427, 35219428, 35219429, 35219430, 35219431, 35219433, 35219437, 35219438, 35219439, 35232921, 35233114, 35233146, 31339155, 35222160, 35222162, 35213795, 35226480, 35226501, 35226507, 30476108, 35222166, 35232444, 35232804, 30843087, 35154880, 35244327, 35244349, 35244354, 35245145, 35245163, 35245164, 35246384, 35246385, 35246398, 35216800, 35219436, 35233098, 35233106, 35244321; INTERNATIONAL 35258119, 35258120, 35258122, 35239852, 35258124, 35222143, 35222149, 35222155, 35239835, 35239836, 35239837, 35239838, 35239855, 35239860, 35242864, 35179778, 35244352, 35246400, 35237525, 35179763, 35179769, 35179775, 35179780, 35179785, 35179786, 35179789, 35200422, 35200431, 35247341, 35252146, 35257876, 35200433, 35247343, 35244353, 35252153, 35237798, 35237799, 35237801, 35237805, 35239739, 35239741, 35239826, 35239829, 35258121, 35258123, 35257953, 35237806, 35252152, 35252709, 35256669, 35258118, 35258135, 35265693, 35222154, 35222158, 35233100, 35239839, 35237808, 35258132, 35258141, 35246419, 35257965, 35257967, 35257969, 35257972, 35257973, 35179739, 35247342, 35258125, 35258127, 35258128, 35258129, 35246389, 35246404, 35250356, 35252123, 35252129, 35239744, 35239817, 35239844, 35239845, 35242868, 35179729, 35257875, 35257874, 35258130, 35237787, 35258139, 35258140, 35237523, 35239740, 35258137, 35258142, 35265695, 35258003, 35237526, 35237810, 35239841, 35265689, 35266602, 35266603, 35252150, 35258126, 35258133, 35265687, 35265690, 35265692, 35266598, 35272212, 35272220, 35272223, 35257974, 35257975, 35239834, 35257968, 35257980, 35257987, 35252147, 35252148, 35257992, 35257995, 35258004, 35258013, 35258015, 35258016, 35258136, 35269726, 35252155, 35257832, 35258131, 35257979, 35257996, 35272213, 35272216, 35252143, 35252151, 35257993, 35257998, 35237809, 35239859, 35242858, 35258138, 35265694, 35266597, 35239843, 35257813, 35257978, 35257984, 35258002, 35257864, 35258018, 35252145, 35252154, 35257877, 35257957, 35252121, 35252135, 35252138, 35222159, 35237796, 35237804, 35237807, 35239624, 35239743, 35239820, 35239821, 35239824, 35239827, 35239850, 35242862, 35266604, 35269733, 35269751, 35270068, 35270074, 35233096, 35233097, 35232800, 35179776, 35265686, 35269723, 35269724, 35269727, 35269729, 35269730, 35269731, 35269732, 35269734, 35269735, 35269739, 35269750, 35269752, 35269754, 35270072, 35270073, 35272211, 35272214, 35272215, 35272217, 35272219, 35272221, 35272222, 35272224, 35272225, 35272226, 35272227, 35272228, 35272229, 35272230, 35272231, 35272232, 35272233, 35272234, 35272235, 35272236, 35272237, 35272238, 35272239, 35272240, 35272241, 35272242, 35272243, 35272245, 35272246, 35272247, 35272248, 35272249, 35272250, 35272251, 35272252, 35272253, 35272254, 35272255, 35272256, 35272257, 35272258, 35272259, 35272260, 35272261, 35272263, 35272264, 35272265, 35272266, 35272267, 35272268, 35272269, 35272271, 35272272, 34973329, 34975026, 35233124, 35249251, 35252113, 35252149, 35252156, 35257865, 35257866, 35257955, 35257960, 35257961, 35257962, 35257963, 35257966, 35257970, 35257976, 35257977, 35257981, 35257983, 35257986, 35257988, 35257989, 35257990, 35257997, 35257999, 35258000, 35258005, 35258006, 35258014, 35233086, 35232924, 35032726, 35274442, 35275472, 35275473, 35275475, 35027242, 35154910, 35172853, 35257856, 35213787, 35237524, 35065618, 35084010, 35179700, 35269725, 35269736, 35269746, 35269747, 35269748, 35269749, 35272244, 35272262, 35272270, 35293823, 34944167, 34975015, 35027260, 35092960, 35112569, 35113161, 35154905, 35270066, 35275476, 35275477, 35275478, 35275481, 34988041, 35239854, 35275482, 34973330, 35269722, 35272218, 34770866.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distribution is Worldwide. Devices are used by healthcare providers in hospital or healthcare clinic settings.
  • Description du dispositif
    LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics.
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.

Manufacturer

Medtronic Emergency Response Systems, Inc.
  • Adresse du fabricant
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA