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-2015-RN-00149-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-20
  • 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-2015-RN-00149-1
  • 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 reboot once in any operating mode if the following sequence occurs:1. in service mode, the status log is cleared 2. prior to exiting service mode, the mrx generates an entry in the status log.3. service mode is exited.The mrx will restart within 8 seconds. if a reboot occurs during clinical use, current device settings and patient record are retained.
  • Action
    A software upgrade will be provided to correct the issue. Philips is advising end users that the MRx can continue to be used prior to receiving the software update. End users are advised that if the MRx reboots during clinical use, continue to treat the patient according to your organization’s protocol, reinitiating therapy if necessary.

Device

Philips HeartStart MRx Monitor/Defibrillators
  • Modèle / numéro de série
    Philips HeartStart MRx Monitor/DefibrillatorsUnits Affected:Model - Serial numbersM3535A: US00100100 to US00578696M3536A: US00100902 to US00576650M3536J: US00209838 to US00332675M3536M: US00500002 to US00553553M3536MC: US00500001 to US00500087M3536M2: US00554176, US00554177, US00554178M3536M5: US00500001 to US00562935M3536M6: US00554358 to US00576619ARTG 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