Events

Rappel de Philips HeartStart MRx Monitor/Defibrillators

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-01276-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-12-08
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01276-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA