Events

Rappel de Lithium Ion batteries used with Philips HeartStart MRx Monitor/Defibrillator

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-00195-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-02-24
  • 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-00195-1
  • 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 philips heartstart mrx monitor/defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from rf energy sources.
  • Action
    Philips is replacing all affected batteries. In the interim Philips is advising that shut down can be avoided by operating the device on AC or external DC power or by following the actions when operating on battery power: - before placing the MRx into use, insert a fully charged battery with five solid green lights on the battery fuel gage when the fuel gauge button is pressed - If your device does not power on, press the fuel gauge button and verify that at least one solid green light is illuminated. If there are no lights, insert a fully charged MRx battery.

Device

Lithium Ion batteries used with Philips HeartStart MRx Monitor/Defibrillator
  • Modèle / numéro de série
    Lithium Ion batteries used with Philips HeartStart MRx Monitor/DefibrillatorMRx Serial Numbers: 11327-0019-P, 11315-0032-P, 11315-0214-P, 11322-0088-P, 11315-0023-P, 11315-0033-P, 11315-0219-P, 11327-0043-P, 11315-0027-P,11315-0036-P, 11315-0391-P, 11327-0044-P, 11315-0031-P, 11315-0109-P, 11322-0084-P, 11322-0088-PARTG Number: 95661
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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