Events

Retiro De Equipo (Recall) de LIFEPAK 20E 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
    134664
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-12-07
  • 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 is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. the symptoms of these failures may include unexpected power on and power off device lock-up or a failure to power on or off any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death. these failures are the result of manufacturing process residue located beneath a component mounted on the power printed circuit board assembly (pcba). there have been no adverse events reported as a result of this issue.

Device

LIFEPAK 20E DEFIBRILLATOR
  • Modelo / Serial
    Model Catalog: 70507-XXXXXX (Lot serial: > 10 numbers contact mfg.); Model Catalog: 99507-XXXXXX (Lot serial: > 10 numbers contact mfg.)
  • Descripción del producto
    LIFEPAK 20E DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

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