Events

Alerte De Sécurité sur HeartStart FR2+ M3860A, M3861A, M3840A and M3841A

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 Electronics Hong Kong Ltd..

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
    2010-06-01
  • 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/press_20100603.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
    Press release
  • Cause
    Recall of automated external defibrillators the department of health (dh) today (june 1) drew public attention to a voluntary recall by the philips electronics hong kong ltd. of four models of automated external defibrillators (aeds) which may have voltage detector problems. the affected models are heartstart fr2+ m3860a, m3861a, m3840a and m3841a. investigation conducted by the manufacturer revealed that the units may contain a component called a voltage detector from lots that have a higher than expected rate of failure, which can cause the aed battery to drain more rapidly than normal or to render the aed unusable. according to philips electronics hong kong ltd, a total of 46 units of the affected models of aeds have been sold to clinics, medical professional organisations and commercial organisations and the company has alerted its purchasers. those who possess the affected models should contact the company by calling its hotline 2876 7578 for advice. dh has not received any report of adverse incidents arising from this issue and will work closely with the company to monitor the recall. 1 jun 2010.

Device

HeartStart FR2+ M3860A, M3861A, M3840A and M3841A

Manufacturer

Philips Electronics Hong Kong Ltd.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH