Events

Rappel de Philips HeartStart XL, Defibrillator/Monitor

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-00209-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-02-25
  • 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-00209-1
  • 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
    An internal component on the heartstart xl power board may malfunction potentially affecting the ability to deliver therapy. specifically, the xl may be unable to charge and deliver a shock. in addition, when used for external pacing, the malfunction may result in a loss of capture.
  • Action
    Philips will be installing replacement power boards to correct the problem. A Philips representative will be in contact with customers to make arrangements for the correction. While awaiting the replacement power board for the device, users may continue to use the HeartStart XL. Identify a readily available backup defibrillator to use in the event the affected HeartStart XL fails to deliver therapy. This action has been closed-out on 11/02/2016.

Device

Philips HeartStart XL, Defibrillator/Monitor
  • Modèle / numéro de série
    Philips HeartStart XL, Defibrillator/MonitorModel Number: M4735AUnits Affected: Units manufactured by Philips between May, 2013 and November, 2013 Serial numbers within the range: US00101665 to US00608704
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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