Events

Alerte De Sécurité sur Siemens Rechargeable Hearing Aids Charger

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

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
    2012-09-06
  • Date de publication de l'événement
    2012-09-06
  • 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_20120906.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: siemens rechargeable hearing aids charger it has come to our attention that medical device manufacturer, siemens has issued a field safety corrective action regarding the euro plug power supply used with chargers for rechargeable hearing aids with the following model numbers: gt-41076-0605 & gtm41076-0605. the manufacturer received 2 reports on a defect of the plug power supply used with chargers for rechargeable hearing aids. the affected component part is the euro plug adapter. in one case a person sustained an electrical shock. when pulling the power supply from the power socket, the plug contacts may separate from the housing and remain in the socket which poses a risk of electrical shock. this error is caused by incomplete ultrasound welding of the euro plug adapter component. if the plug contacts should separate from the power supply and remain in the power socket, the manufacturer provided the following advice to affected users: do not touch the contacts which are stuck in the power socket disconnect the power socket from the power grid and remove the separated plug contacts.Do not touch any bare metal parts during removal. if you are not sure, ask an electrician for assistance. take the damaged power supply to your acoustician. the manufacturer also advised affected users to contact their hearing aid acoustician within 2 weeks who will inspect the euro plug adapter. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 september 2012.

Device

Siemens Rechargeable Hearing Aids Charger
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Siemens Rechargeable Hearing Aids Charger
  • Manufacturer
    Siemens

Manufacturer

Siemens