Events

Retiro De Equipo (Recall) de Device Recall Powerheart AED

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
    54517
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1246-2010
  • Fecha de inicio del evento
    2010-02-03
  • Fecha de publicación del evento
    2010-04-06
  • 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=88619
  • 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
    A component of the aed device may fail during a rescue attempt and the aed will not be able to deliver therapy.
  • Acción
    The firm began initial notification on 2/3/2010 by sending letters to all affected consignees via USPS certified mail (domestic) and FedEx (international). Also on 2/3/2010 the firm issued a global press release and posted recall information on their website. Customers are instructed to remove their affected units from service, and have been given instructions for returning their affected devices. Replacement AED(s) will be sent as they are available. For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. AED195@cardiacscience.com to arrange for replacement(s).

Device

Device Recall Powerheart AED
  • Modelo / Serial
    SERIAL NUMBERS:  4124722, 4152972, 4183430, 4196741, 4243133, 4282982, 4282983, 4282984, 4282985, 4282986, 4282987, 4282988, 4282989, 4282990, 4282991, 4282992, 4282993, 4282994, 4282995, 4282996, 4282997, 4282998, 4282999, 4283000, 4283001, 4287592, 4287593, 4287594, 4287595, 4287596, 4287597, 4287598, 4287599, 4287600, 4287601, 4287602, 4287603, 4287604, 4287605, 4287606, 4287607, 4287608, 4287609, 4287610, 4287611, 4287612, 4287613, 4287614, 4287615, 4287616, 4287617, 4287618, 4287619, 4287620, 4287621, 4287622, 4287623, 4287624, 4287625, 4287626, 4287627, 4287628, 4287629, 4287630, 4287631, 4287632, 4287633, 4287634, 4287635, 4287636, 4287637, 4287638, 4287639, 4287640, 4287641, 4287642, 4287643, 4287644, 4287645, 4287646, 4287647, 4287648, 4287649, 4287650, 4287651, 4287652, 4287653, 4287654, 4287655, 4287656, 4287657, 4287658, 4287659, 4287660, 4287661, 4287662, 4287663, 4287664, 4287665, 4287666, 4287667, 4287668, 4287669, 4287670, 4287671, 4287672, 4287673, 4287674, 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AND 4301103.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Distributed to health care and emergency medical personnel and US Gov't/Military in the US and the following 44 countries: AUSTRALIA, BELGIUM, BELIZE, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, DENMARK, EGYPT, FRANCE, GERMANY, GRENADA, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TRINIDAD, AND GREAT BRITAIN.
  • Descripción del producto
    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). || Brand name: Cardiac Science. || Product name: Powerheart. || Device Operation: Fully automatic. || Color: Yellow. || Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device use, pad placement and CPR performance, as compared to the basic prompts.) || CPR Metronome: Yes. || Rescue Ready Indicator: Yes. || Text Display: Yes. || ECG Display: No.
  • 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