Events

Rappel de Device Recall Powerheart 9390E automated external defibrillator

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 Cardiac Science Corporation.

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
    55603
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1810-2010
  • Date de mise en oeuvre de l'événement
    2009-12-18
  • Date de publication de l'événement
    2010-06-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91319
  • 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
    automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    The k302 relay switch of the g3 series aed product line may experience an early failure. if the k302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver therapy.
  • Action
    Customer notification letters were mailed to US end users and distributors (final consignees) between December 18 and 23, 2009 by USPS certified mail, return receipt requested. Notification letters were sent by FedEx to Canadian distributors (final consignees) on December 23, 2009. Secondary consignee (distributor) letters were mailed on December 23, 2009. Letters advise user to check the status indicator on front of AED to determine if it is rescue ready. Users are advised to keep the AED in service and to perform the Daily and Monthly Scheduled Maintenance as outlined in the Operator and Service Manual. Questions about this communication should be addressed to 1.877.901.1788 toll free from inside the US, or to email .

Device

Device Recall Powerheart 9390E automated external defibrillator
  • Modèle / numéro de série
    Serial Numbers: 4259985, 4260065, 4260137, 4260148, 4260174, 4260179, 4260181, 4261110, 4261111, 4261112, 4261113, 4261114, 4261115, 4261116, 4261117, 4261118, 4261119, 4261120, 4261121, 4261122, 4261123, 4261125, 4261126, 4261127, 4261128, 4261129, 4261130, 4261131, 4261132, 4261133, 4261134, 4261136, 4261138, 4261139, 4261140, 4261141, 4261142, 4261143, 4261144, 4261145, 4261147, 4261149, 4261150, 4261151, 4261153, 4261154, 4261155, 4261156, 4261157, 4261158, 4261160, 4261161, 4261162, 4261163, 4261164, 4261166, 4261168, 4261169, 4261170, 4261172, 4261174, 4261175, 4261177, 4261178, 4261179, 4261180, 4261181, 4261182, 4261183, 4261184, 4261185, 4261186, 4261188, 4261189, 4261190, 4261216, 4261217, 4261284, 4261285, 4261292, 4261299, 4261300, 4261301, 4261305, 4261306, 4261308, 4261312, 4261313, 4261317, 4261319, 4261320, 4261321, 4261325, 4261326, 4261329, 4261330, 4261332, 4261333, 4261342, 4261343, 4261348, 4261351, 4261352, 4261355, 4261356, 4261358, 4261360, 4261361, 4261365, 4261370, 4261381, 4261382, 4261383, 4261384, 4261385, 4261386, 4261387, 4261388, 4261394, 4261395, 4261396, 4261397, 4261398, 4261399, 4261400, 4261401, 4261402, 4261403, 4261404, 4261405, 4261406, 4261407, 4261408, 4261409, 4261410, 4261411, 4261412, 4261413, 4261414, 4261415, 4261416, 4261417, 4261420, 4261422, 4261423, 4261425, 4261449, 4261450, 4261451, 4261463, 4261465, 4261473, 4261475, 4261476, 4261477, 4261478, 4261479, 4261480, 4261481, 4261482, 4261483, 4261484, 4261485, 4261486, 4261487, 4261488, 4261489, 4261490, 4261492, 4261495, 4261496, 4261498, 4261499, 4261500, 4261501, 4261502, 4261503, 4261505, 4261506, 4261507, 4261508, 4261512, 4261513, 4261514, 4261515, 4261516, 4261517, 4261518, 4261519, 4261520, 4261522, 4261523, 4261524, 4261526, 4261527, 4261528, 4261529, 4261530, 4261531, 4261532, 4261534, 4261535, 4261536, 4261537, 4261538, 4261539, 4261540, 4261541, 4261542, 4261543, 4261544, 4261545, 4261546, 4261547, 4261548, 4261549, 4261551, 4261552, 4261554, 4261555, 4261557, 4261558, 4261559, 4261560, 4261561, 4261562, 4261563, 4261564, 4261565, 4261566, 4261567, 4261568, 4261570, 4261571, 4261572, 4261573, 4261574, 4261575, 4261576, 4261577, 4261579, 4261580, 4261586, 4261587, 4261592, 4261597, 4261598, 4261605, 4261608, 4261610, 4261611, 4261613, 4261614, 4261615, 4261617, 4261618, 4261621, 4261623, 4261624, 4261626, 4261628, 4261630, 4261631, 4261632, 4261633, 4261634, 4261635, 4261636, 4261637, 4261638, 4261639, 4261640, 4261641, 4261642, 4261643, 4261644, 4261645, 4261646, 4261647, 4261648, 4261649, 4261650, 4261651, 4261652, 4261653, 4261654, 4261656, 4261657, 4261660, 4261662, 4261663, 4261664, 4261665, 4261666, 4261670, 4261672, 4261676, 4261678, 4261679, 4261680, 4261683, 4261688, 4261689, 4261690, 4261691, 4261692, 4261695, 4261696, 4261697, 4261700, 4261709, 4261711, 4261712, 4261713, 4261714, 4261716, 4261718, 4261721, 4261726, 4261727, 4261729, 4261733, 4261734, 4261737, 4261739, 4261744, 4261745, 4261746, 4261747, 4261748, 4261750, AND 4261751.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Domestic: 323 units to distributors and end users. Canada: 9 units to 2 distributors.
  • Description du dispositif
    Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). || Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • Adresse du fabricant
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Société-mère du fabricant (2017)
    Cardiac Science Corporation
  • Source
    USFDA