Events

Alerte De Sécurité sur Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532 and 92533

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

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
    2009-11-18
  • 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_20091119.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
    Field correction of automated external defibrillators the department of health (dh) today (november 18) alerted the public of a voluntary field correction by the manufacturer and supplier of two series of automated external defibrillator (aed)which may fail to deliver therapy during a resuscitation attempt. the affected models are powerheart 9300a, 9300c, 9300d, 9300e, 9300p, 9390a, 9390e, and cardiovive 92531, 92532 and 92533. the manufacturer, cardiac science corporation, estimated that one in 75,000 aeds manufactured between august 2003 and august 2009 may suffer the failure. a software update will be available by may 2010 to fix the problem. the company advises users to keep their aeds in service and follow the normal testing and maintenance procedures. about 262 aed of the two series of models have been sold to 157 users in hong kong. the local sole supplier of the affected aed, pacific medical systems ltd, could be contacted at 2108 4005 for advice. “users should follow the recommendations of the manufacturer and make contingency provisions in case the aed could not deliver therapy,” a spokesman for the department said. “the department had alerted the hospital authority, private hospitals, nursing homes, relevant institutions and medical association of the voluntary field action. “so far, no reports on adverse events arising from this issue have been received. “the department will closely monitor this field correction,” he said. ends/wednesday, november 18, 2009.

Device

Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532 and 92533
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Field Correction of Automated External Defibrillators
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation