Events

Retiro De Equipo (Recall) de Philips HeartStart MRx Monitor/Defibrillators

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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
    RC-2014-RN-01276-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-12-08
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01276-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The mrx could contain incorrect internal software settings, causing the following two 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. there is a potential for a delay in therapy due to insufficient battery power.
  • Acción
    Philips is initiating a correction that will consist of replacement of the therapy capacitor and reset of internal software settings. Prior to receiving correction, customers can continue to use the affected MRx provided that they follow workaround steps identified in the customer letter. These steps will prevent further accelerated degradation of the therapy capacitor, and will eliminate the above described behaviour for no/low battery conditions.

Device

Philips HeartStart MRx Monitor/Defibrillators

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA