Events

Rappel de LIFEPAK 15 Monitor/Defibrilators with End-Tidal CO2 (EtCO2) functionality

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Physio-Control Australia Pty 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-00296-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-02
  • 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-00296-1
  • 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
    An issue has been identified where the etco2 reading on the lifepak 15 can intermittently show a value of “xxx” after start-up or during device operation. an investigation by the manufacturer of the etco2 module has revealed that compressed air may have contaminated filters within in the module. as a result of this filter contamination, the etco2 display on the device will provide a reading of “xxx”. there may be solid or dashed lines present on the device display in the place of an etco2 waveform and the service led will be illuminated. in this situation the etco2 monitoring functionality will no longer be available.
  • Action
    Physio-Control is advising users who experience the “XXX” after power-up or during device operation to make immediate contact to arrange for servicing of the affected device. Users are further advised that if the issue does not occur, to continue performing the daily device self-tests as indicated in the Operating Instructions and the device is safe to use.

Device

LIFEPAK 15 Monitor/Defibrilators with End-Tidal CO2 (EtCO2) functionality
  • Modèle / numéro de série
    LIFEPAK 15 Monitor/Defibrilators with End-Tidal CO2 (EtCO2) functionalityMultiple Serial NumbersEtCO2 moduleLot Codes: 1506, 1520, 1532, 1544, 1551ARTG Number: 215648
  • Manufacturer
    Physio-Control Australia Pty Ltd

Manufacturer

Physio-Control Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA