Events

Alerte De Sécurité sur heartstart fr3 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 Philips Healthcare.

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
    2012-03-06
  • 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_20120306b.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
    Field safety notice: heartstart fr3 automated external defibrillators the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning heartstart fr3 automated external defibrillators (aeds) manufactured by philips healthcare. the affected model numbers were 861388 and 861389 and distributed between may 24, 2011 and september 13, 2011. the software on aeds distributed during this time period requires an update, in order to address two urgent aspects. the first can, in an estimated one of 21,000 power cycles, leave the device in an activated but unresponsive state and thus not available for use when needed in an emergency unless the battery is removed and reinstalled. the second can result in a language loaded onto the fr3 that is different than the language selected by the user during the language load process. the manufacturer will provide an fr3 software update kit to correct the above two aspects. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm according to the local supplier, the affected device has not been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

heartstart fr3 automated external defibrillators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: HeartStart FR3 Automated External Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH