Events

Alerte De Sécurité sur heartstart frx, heartstart home, and heartstart onsite 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.

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
    2018-03-14
  • Date de publication de l'événement
    2018-03-14
  • 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_20180314b.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: philips heartstart frx, heartstart home, and heartstart onsite automated external defibrillators the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning heartstart frx, heartstart home, and heartstart onsite automated external defibrillators (aeds), manufactured by philips. the manufacturer has become aware of a specific issue with one of the electric components (a resistor) in approximately 660,000 aeds that were manufactured between 2002-2013. according to the manufacturer, virtually all of these resistor-related failures were detected through the device’s automatic self-testing, alerting the user by issuing audible chirps. the in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest victim is in need of shock therapy. in the extremely rare circumstances, the automated tests fail to detect the aed’s inability to function normally, and fail to deliver a shock when one is needed, putting patients at risk of not receiving adequate therapy for their vf or vt, potentially resulting in serious injury, or even death. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-5-to-9-march-2018 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 march 2018.

Device

heartstart frx, heartstart home, and heartstart onsite automated external defibrillators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips HeartStart FRx, HeartStart Home, and HeartStart OnSite automated external defibrillators
  • Manufacturer
    Philips

Manufacturer

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