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-2017-RN-00401-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-03-27
  • 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-2017-RN-00401-1
  • 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 possibility of abnormal device behaviours has been identified in the heartstart mrx monitor/defibrillator. the device may exhibit the following issues:1. if the battery connecting pins (in the battery compartment of the heartstart mrx monitor/defibrillator) become damaged or contaminated, it could result in a poor electrical connection that may cause the mrx to either (i) not power on or (ii) repetitively reboot, when used on battery power only 2. after unplugging the device from ac mains, there are two abnormal behaviours of the heartstart mrx monitor/defibrillator that may occur:a) after the user depresses the charge button, the device attempts to charge, and after approximately 20 seconds, generates the “shock equipment malfunction” error message and is unable to deliver shock therapy.B) pacing may cease without warning. these device behaviours continue until the unit is reset.Either problem could potentially delay monitoring or therapy.
  • Action
    Philips is advising customers to take the following corrective actions: Issue 1, inspect the HeartStart MRx battery compartment connections on the device. Include this step as part of a routine Operational Check to verify that the battery connector pins are clean, fully extended, not bent, and without residue; and Issue 2, if the External Power Indicator light above the MRx display remains illuminated after the device is unplugged from AC mains power, leave the device unplugged, remove and reinsert the battery and confirm that the Indicator has turned off. Customers are requested to refer to their recall notification letter for further important details.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modèle / numéro de série
    Philips HeartStart MRx Monitor/DefibrillatorModel Numbers: M3535A, M3536A, and military bundles Units: M3535A (M3535ATZ)M3536A (M3536ATZ)M3536M, M3536MCM3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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