Alerte De Sécurité sur MEDUCORE Easy and LIFEPAK 500

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Weinmann / Medtronic.

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
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Alert on performance of two automated external defibrillators the department of health (dh) draws public's attention to performance defects in two brands of automated external defibrillators (aeds), meducore easy and lifepak 500, made respectively by two medical device manufacturers, weinmann and medtronic, because of potential malfunctions in both. the two incidents come to dh's notice through its surveillance system on medical device mishaps. both devices are designed for use during cardiopulmonary resuscitation. according to weinmann, the time allotted for charging the capacitor in meducore easy is insufficient for a full charge and hence may result in device failure. the incomplete charging can be eliminated through a modification to the firmware and weinmann urges customers to send their devices to their local suppliers for upgrading. the second incident involves lifepak 500 aed, created by physio control, a division of medtronic. it is noted that the electronic component on the main printed circuit board of a certain number of devices is susceptible to moisture, which could again cause malfunction as a result. physio control remarks that two patients were reported as unable to be resuscitated. however, definitive causal conclusions still remain to be determined. nevertheless, the company is advising customers to contact their local service personnel for their follow-up. dh's preliminary inquiries on the two manufacturers, including their local suppliers, reveal that while no meducore easy device has been supplied to hong kong, two lifepak 500 aeds are available locally. both are only for use in demonstrations and thus not meant for sale. "despite the above, the possibility of possession of the above devices by individual customers cannot be ruled out and given the dreaded potential consequence of failed resuscitation, dh opts that a public announcement is warranted as a matter of prudence," a spokesman for dh explains. so far, dh has not received any report of adverse incident related to the two brands of aeds in hong kong. "anyone who has the aeds in question should take note of the announcement and act according to the corrective actions suggested by the manufacturers as soon as possible," the spokesman reminds the public.


  • Modèle / numéro de série
  • Description du dispositif
    Press release: Alert on performance of two automated external defibrillators
  • Manufacturer