Events

Avis De Sécurité sur LIFEPAK® CR Plus Automatic External Defibrillator

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Physio-Control.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2010(08)
  • Date
    2010-07-19
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/lifepak-cr-plus-automatic-external-defibrillator&id=0b8bf825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    The potential for the lifepak® cr plus to not deliver therapy still exists due to a device upgrade that has not been completed on all of the affected devices on the irish market.
  • Action
    1. Ensure the appropriate personnel are made aware of this notice.  2. Identify affected LIFEPAK® CR Plus defibrillators (Please see Attachment 1 for affected serial numbers)  3. Confirm if defibrillators have been upgraded by Oxygen Care (repair and servicing company for Physio-Control products in Ireland) in relation to this issue.  4. If any of the affected defibrillators has not been upgraded, immediately contact Medtronic or Oxygen Care (see contact details below) to arrange the correction of the defibrillator, and follow the recommendations listed in the FSN.  5. Perform regular monthly inspection as per LIFEPAK® CR Plus operating instructions AND verify that the voice prompt is heard at power on.  6. If, at any time, the voice prompt is not heard or any other indicator displays bar “OK”, immediately contact Medtronic.

Device

LIFEPAK® CR Plus Automatic External Defibrillator
  • Modèle / numéro de série
  • Description du dispositif
    LIFEPAK® CR Plus Automatic External Defibrillator
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    HPRA