Events

Rappel de 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-00231-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-03
  • 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-00231-1
  • 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 mrx therapy board may malfunction potentially affecting the ability to deliver therapy. specifically, the mrx 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 during pacing.The mrx may display a red x in the ready for use (rfu) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing.
  • Action
    Philips is initiating a correction to the affected devices. A hardware upgrade will be provided to customers with affected devices. Philips is advising users that they can continue to use their MRx prior to receiving the hardware upgrade, provided that if it is observed that the MRx is displaying a Red X in the Ready For Use (RFU) indicator during automated tests, a failure has been detected that may prevent the delivery of a shock or pacing due to this issue. If this occurs, remove from use and call for a service. Identify a readily available back up defibrillator to use in the event the affected MRx fails to deliver therapy.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modèle / numéro de série
    Philips HeartStart MRx Monitor/DefibrillatorModel numbers: M3535A, M3536A, M3536M, M3536M4, M3536M6, 861288, 861289, 861464, 861483, and 861491Units Affected: Serial numbers within the range US00100204 to US00570921ARTG 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