Events

Alerte De Sécurité sur physio-control lifepak cr plus and lifepak express automated external defibrillators

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Physio-Control Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-07-06
  • Date de publication de l'événement
    2016-07-06
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160706.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: physio-control lifepak cr plus and lifepak express automated external defibrillators the food and drug administration (fda) of the united states posted a medical device safety alert concerning lifepak cr plus and lifepak express automated external defibrillators (aed), manufactured by physio-control inc. the affected aeds may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. according to the manufacturer, a defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. for details, please refer to the fda enforcement report website: http://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm (recall number: z-2100-2016) if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 july 2016.

Device

physio-control lifepak cr plus and lifepak express automated external defibrillators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Physio-Control LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators
  • Manufacturer
    Physio-Control Inc

Manufacturer

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