Events

Retiro De Equipo (Recall) de Device Recall Powerheart 9390E automated external defibrillator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cardiac Science Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    55603
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1810-2010
  • Fecha de inicio del evento
    2009-12-18
  • Fecha de publicación del evento
    2010-06-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91319
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Domestic: 323 units to distributors and end users. Canada: 9 units to 2 distributors.
  • Descripción del producto
    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
  • Dirección del fabricante
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Empresa matriz del fabricante (2017)
    Cardiac Science Corporation
  • Source
    USFDA