Events

Rappel de HeartStart HS1 & FRx

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
    22713
  • Date de mise en oeuvre de l'événement
    2018-03-13
  • 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
    The manufacturer has become aware of a specific issue with one of the electric components (a resistor) in approximately 660,000 aeds that were manufactured between 2002-2013. virtually all of these resistor-related failures were detected through the device's automatic self-testing, alerting the user by issuing audible chirps. the in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest victim is in need of shock therapy.
  • Action
    Manufacturer to issue advice regarding use

Device

HeartStart HS1 & FRx
  • Modèle / numéro de série
    Model: HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs, Affected:
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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