Events

Alerte De Sécurité sur FRED easy & FRED easy Life 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 Nessler.

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
    2012-05-22
  • Date de publication de l'événement
    2012-05-22
  • 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_20120522b.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
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: schiller medical fred easy & fred easy life defibrillators the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning fred easy & fred easy life defibrillators manufactured by schiller medical. according to schiller medical, two problems have been identified regarding “transistor charge error” message and quality of the electrodes. transistor charge error: on some devices, during use, or during a self test, a message “transistor charge error” has occurred. in the analysed cases (field and laboratory results), all occurrences were “false positive”, the devices were not affected by a failure. as a consequence, the device is unavailable until it is restarted. the occurrence of the failure is estimated to 0.2%. the corrective action consists in a software update, which prevents the occurrence of the “false positive”. electrodes: a decline in the quality, before expiry date, has been observed for some schiller electrodes manufactured by nessler (p/n 0-21-0000, 0-21-0003, 0-21-0020, 0-21-0021, 0-21-0013, 0-21-0024, 2.155056, 2.155057, w1410241, w1404262). the consequences were a decrease of survival chances for some patients, due to the lack of heart rhythm analysis. all schiller electrodes which are still on the market, with a valid expiry date and manufactured by nessler, will be exchanged by new schiller electrodes manufactured by leonhard lang. according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted 22 may 2012.

Device

FRED easy & FRED easy Life Defibrillators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Schiller Medical FRED easy & FRED easy Life Defibrillators
  • Manufacturer
    Nessler

Manufacturer

Nessler