Events

Retiro De Equipo (Recall) de LIFEPAK 1000 SYSTEM - DEFIBRILLATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHYSIO-CONTROL CANADA SALES LTD.

¿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
    29790
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2017-01-13
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Physio-control has received complaints that the lifepak 1000 defibrillator is unexpectedly powering off during device usage. this unexpected shut down is due to an intermittent connection between the battery and device contacts. a defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt which may expose patients to the risk of serious harm or death. this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this has been observed to occur in devices that are exposed to vibration and have a battery installed for extended time without being removed from the lifepak 1000 for inspection and then reinstalled.

Device

LIFEPAK 1000 SYSTEM - DEFIBRILLATOR
  • Modelo / Serial
    Model Catalog: 99425-XXXXXX (Lot serial: > 1000 numbers contact mfg)
  • Descripción del producto
    LIFEPAK 1000 DEFIBRILLATOR
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

PHYSIO-CONTROL CANADA SALES LTD
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC