Events

Rappel de Philips HeartStart MRx Monitor/Defib with Q-CPR Meter

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Philips Medical Systems (USA).

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
    16288
  • Date de mise en oeuvre de l'événement
    2014-02-24
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    When the heartstart mrx is in aed mode, the q-cpr meter is designed to display the 'do not touch the patient' icon during the shock advisory analysis period. if the user continues to deliver chest compressions when the shock advisory analysis begins, the 'do not touch the patient' icon may incorrectly remain on the screen after analysis or shock delivery is complete., when the heartstart mrx is in manual mode, the q-cpr meter is designed to display the 'do not touch the patient' icon when the device is charging to the selected energy. if the clinician continues to provide chest compressions while the device is charging, the q-cpr meter 'do not touch the patient" icon may incorrectly remain on the screen after shock delivery is complete.
  • Action
    Software to be upgraded

Device

Philips HeartStart MRx Monitor/Defib with Q-CPR Meter
  • Modèle / numéro de série
    Model: Model numbers M3535A and M3536A with Q-CPR™ Meter Option B08, Affected:
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA