Events

Retiro De Equipo (Recall) de PHILLIPS HEARTSTART HS1 HOME DEFIBRILLATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS 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
    28123
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-02-23
  • 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
    Philips has become aware of a specific issue with one of the electric components (a resistor) in approximately 660000 aeds that were manufactured between 2002-2013. virtually all of these resistor-related failures were detected through the device's automatic self-testing alerting the user by issuing audible chirps. the in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest victim is in need of shock therapy.

Device

PHILLIPS HEARTSTART HS1 HOME DEFIBRILLATOR
  • Modelo / Serial
    Model Catalog: M5068A (Lot serial: N/A); Model Catalog: M-5066A-ABA (Lot serial: N/A); Model Catalog: M5068A-ABF (Lot serial: N/A); Model Catalog: M5066A-ABF (Lot serial: N/A); Model Catalog: 989803169631 (Lot serial: N/A); Model Catalog: M5066A (Lot serial: N/A); Model Catalog: 861304 (Lot serial: N/A)
  • Descripción del producto
    PHILIPS HEARTSTART HS1 HOME DEFIBRILLATOR;PHILIPS HEARTSTART HS1 ONSITE DEFIBRILLATOR;HEARTSTART FRX AUTOMATED EXTERNAL DEFIBRILLATOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC