Events

Retiro De Equipo (Recall) de HEARTSTART MRX DEFIBRILLATOR/MONITOR

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
    91530
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-11-21
  • 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 that the heartstart mrx defibrillator/monitor may contain incorrect internal software settings causing the following two (2) issues: 1. the device will perform the weekly automated tests hourly which could cause the therapy capacitors to degrade sooner than intended. 2. while connected to ac or dc power and with no battery installed or the battery installed has a charge level of less than 10% the ready for use (rfu) indicator will not provide the expected low battery indication (flashing red x with audible chirp). instead the rfu will show a flashing black hourglass indicating that sufficient battery power is available for device operation. note: once the device is disconnected from ac or dc power the rfu indicator provides the appropriate low battery indications. in addition all other battery charge indicators continue to operate normally including the onscreen battery fuel gauges low battery messages and low battery alarms. the led charge level indicators on the batteries themselves also operate normally.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Modelo / Serial
    Model Catalog: M3536A (Lot serial: ALL); Model Catalog: M3535A (Lot serial: ALL)
  • Descripción del producto
    HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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