Events

Retiro De Equipo (Recall) de Device Recall LIFEPAK 12 DEFIBRILLATOR/MONITOR

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 Physio Control, Inc..

¿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
    54005
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0811-2010
  • Fecha de inicio del evento
    2009-03-31
  • Fecha de publicación del evento
    2010-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87123
  • 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
    Affected devices contain a biphasic pcba that may have a solder defect on the h bridge component that could prevent the device from providing a defibrillation shock. there could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. delay or prevention of defibrillation therapy may contribute to the death of a viable patient.
  • Acción
    Consignees were sent a notification letter dated March 2009 that explained firm representatives would follow up with each customer within 30 days to arrange an update to affected devices. Affected Biphasic PCBAs will be replaced. Customers advised to keep the devices in use and to continue to perform daily User Test.

Device

Device Recall LIFEPAK 12 DEFIBRILLATOR/MONITOR
  • Modelo / Serial
    Part Number: LP12, VLP12-02-(various dash numbers).  Serial Numbers (non-contiguous): 8529728, 8529728, 9210418, 9210419, 9599334, 10128750, 10132851, 10248200, 10389064, 11120818, 11244332, 11252979, 11252980, 11252981, 11289300, 11311777, 11311778, 11311782, 11311787, 11316922, 11372139, 11424301, 11424819, 11471546, 11568711, 11610477, 11766215, 11766216, 11766222, 11767531, 11767565, 11877154, 12007118, 12007124, 12007129, 12007131, 12007135, 12009524, 12009528, 12030152, 12209828, 12209830, 12209832, 12209834, 12551932, 12551934, 12551936, 12551937, 12551939, 12776733, 12776734, 12779439, 12779439, 12789243, 13165363, 13269232, 13423039, 13434816, 13434837, 13522303, 13536842, 13704769, 13704770, 13870608, 13993048, 14008074, 14008075, 14201185, 14201186, 14201187, 30646561, 32117838, 32117838, 32117839, 32117839, 32117840, 32117840, 37125611, 37125612, 37125617, 37125743, 37125751, 37125752, 37125753, 37126327, 37126328, 37126329, 37126330, 37126331, 37126332, 37126333, 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  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Distributed domestically and internationally to hospitals, clinics, etc. Foreign distribution to the following countries: Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands, and Puerto Rico.
  • Descripción del producto
    Biphasic LIFEPAK 12 defibrillator / monitor.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • Dirección del fabricante
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA