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-00187-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-02-21
  • 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-00187-1
  • 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
    A component of the mrx processor board may be susceptible to damage from electrostatic discharge (esd). damage to these components can disrupt ecg and spo2 functionality leading to an inability to perform:- demand mode pacing- 12 lead ecg acquisition and analysis- ecg monitoring via leads- pulse oximetry (spo2)the presence of this condition will be displayed on the ready for use (rfu) indicator as a solid red x with periodic audio chirp.
  • Action
    A hardware upgrade will be provided to correct the issue. Philips is advising healthcare professionals that the MRx can continue to be used prior to receiving the hardware update. Philips is also advising users to immediately contact their Philips authorised service personnel if it is observed that the MRx is displaying a solid red ‘X’ in the RFU indicator and displaying the 'ECG Equip Malfunction' INOP, a failure that may disable some ECG and SpO2 functionality.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modèle / numéro de série
    Philips HeartStart MRx Monitor/DefibrillatorModel numbers M3535A, M3536A, M3536J, M3536MCSerial numbers within the following ranges:Model M3535A: US00100100 to US00541372Model M3536A: US00100902 to US00541375Model M3536J: US00209838 to US00332675Model M3536MC: US00500001 to US00500020 ARTG 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