Events

Rappel de Cardiac Science Powerheart G5 Automated External Defibrillators

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 Cardiac Science Inc.

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
    16198
  • Date de mise en oeuvre de l'événement
    2014-02-19
  • 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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Cause
    Cardiac science has determined certain powerheart g5 automatic external defibrillators (aeds) shipped between june 21, 2012, and march 1, 2013, may have been manufactured with a defective electrode connector. some of these g5 aeds have been found with missing spring contacts in the electrode connector assembly. when the spring is missing, the aed may not recognise that the pads have been placed on the patient during a rescue attempt. the aed voice prompts will progress until they reach the pads placement (peeled) step. at that point the aed will, regardless of whether the pads are placed onto the patient's chest or not, continuously repeat "place pads firmly onto patient's chest..." after 2 minutes, the pad placement prompting will time out and the aed will begin cpr mode. if the issue occurs, the aed may not be able to deliver therapy during a rescue attempt and may affect resuscitation of the patient. this could lead to serious adverse health events or death.
  • Action
    Product to be modified

Device

Cardiac Science Powerheart G5 Automated External Defibrillators
  • Modèle / numéro de série
    Model: Model: G5A-31A, Affected:
  • Manufacturer
    Cardiac Science Inc

Manufacturer

Cardiac Science Inc