Events

Alerta De Seguridad para Siemens Rechargeable Hearing Aids Charger

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Siemens.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-09-06
  • Fecha de publicación del evento
    2012-09-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120906.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Siemens Rechargeable Hearing Aids Charger
  • Manufacturer
    Siemens

Manufacturer

Siemens