Events

Rappel de Philips HeartStart Home and OnSite (HS1) Automated External 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-00339-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-17
  • 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-00339-1
  • 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
    Phillips has determined in a limited number of heartstart home and onsite (hs1) aeds, one or both contact pins may be contaminated by residue from the soldering process. this contamination could prevent an adequate connection between the pads cartridge and the aed resulting in the device being unable to deliver therapy.
  • Action
    End users are requested to identify if they have an affected AED and contact Philips immediately. Philips is advising that if no alternative is available that AEDs should be kept in service until replacement unit can be supplied. This action has been closed-out on 18/02/2016.

Device

Philips HeartStart Home and OnSite (HS1) Automated External Defibrillators
  • Modèle / numéro de série
    Philips HeartStart Home and OnSite (HS1) Automated External DefibrillatorsModel numbers: M5066A and M5068ASerial number range : A13G-00047 to A136-006576ARTG number: 92346
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA