Events

Alerte Ou Avis De Sécurité sur Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom 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
    Safety alert / Field Safety Notice
  • Date
    2016-10-13
  • Date de publication de l'événement
    2016-10-13
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/automatic-external-defibrillator-aed-lifepak-cr-plus-and-lifepak-express-risk-of-failure-to-deliver-a-shock
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
    LIFEPAK CR Plus AEDs or LIFEPAK EXPRESS AEDs may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened. The problem is due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock.
  • Cause
    Manufactured by physio-control – risk of delay to defibrillation due to an intermittent component failure. specific serial numbers are affected.
  • Action
    Ensure that all those responsible for the AED follow the instructions in the manufacturer’s Field Safety Notice FSN To check if your AED is affected call Physio-Control customer support or visit their website and go to ‘Search Affected Devices’ and enter the serial numbers. If the AED is faulty, remove the unit from service and contact Physio-Control to arrange for it to be corrected. If you have already acted on this FSN, no further action is required.

Device

Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS
  • Modèle / numéro de série
  • Description du dispositif
    The AED can be found in hospitals and in public places (eg railway stations, village halls and supermarkets).
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Adresse du fabricant
    Physio-Control Operations, Netherlands Telephone: 0808 258 0094Email: RS.EMEArecall@physio-control.com
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    MHRA