Events

Alerte De Sécurité sur HeartStart MRx/MRxE M3535A and HeartStart XL M4735A

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
    2009-04-24
  • 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_20090425.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 (april 24) alerted the public of a voluntary recall by the manufacturer of two models of automated external defibrillator (aed) which have switch problem. the affected models are heartstart mrx/mrxe m3535a and heartstart xl m4735a. investigation conducted by the manufacturer, philips healthcare, revealed that failures are more likely to occur in devices that have been exposed to high heat and humidity, which contribute to accelerated internal degradation of switch components over time. about 270 aed of the two models have been introduced to hong kong, mostly to public and private hospitals. philips healthcare has alerted its purchasers. people should not use the aed of the affected models and contact the company by calling its hotline 2876 7578 for advice. dh has not received any report of adverse events arising from this issue and will closely monitor the recall. ends.

Device

HeartStart MRx/MRxE M3535A and HeartStart XL M4735A
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of Automated External Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

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