Events

Alerte De Sécurité sur HeartStart FRx and HeartStart HS1 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
    2013-12-04
  • 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_20131204a.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
    Safety alert on philips heartstart frx and heartstart hs1 automated external defibrillators the department of health (dh) today (december 4) drew the public's attention to a safety alert issued by philips healthcare concerning its three models of automated external defibrillators (aeds), namely heartstart frx, heartstart hs1 home and heartstart hs1 onsite, as the devices may be unable to deliver the needed electric shock in a cardiac emergency situation. the dh, through its routine surveillance on medical devices, noticed the above alert from the us food and drug administration. according to philips healthcare, the devices manufactured between 2005 and 2012 could incorrectly indicate that they are ready for use yet be unable to deliver the needed electric shock. according to the local supplier, philips electronics hong kong ltd, the affected models are marketed in hong kong as heartstart frx and heartstart hs1. the dh's enquiries with the supplier revealed that 374 units of heartstart frx and heartstart hs1 have been distributed to hospitals, clinics, schools and other venues. a dh spokesman said, "all owners of the affected aeds are advised to contact their supplier for technical support and advice. they should keep the affected aeds in service until such advice or a replacement is available." "so far, the dh has not received any relevant reports of adverse incidents related to the affected aeds in hong kong," the spokesman added. the company has set up a customer service hotline, 800 969 619, to answer related enquiries. the dh has informed public and private hospitals and relevant associations about the alert and shall continue to liaise with the supplier on the follow-up actions. ends/wednesday, december 4, 2013 issued at hkt 20:46.

Device

HeartStart FRx and HeartStart HS1 automated external defibrillators
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety alert on Philips HeartStart FRx and HeartStart HS1 automated external defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

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