Events

Alerta De Seguridad para Battery pack for MEDUCORE Easy

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

¿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
    2017-02-21
  • Fecha de publicación del evento
    2017-02-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170221.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: battery pack for meducore easy the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a medical device safety alert concerning the battery pack for meducore easy, manufactured by weinmann emergency medical technology [model: wm 40155; serial number: below 20000]. the manufacturer has found that in very rare cases, the battery pack may fail. in the fault situation, it would no longer be possible to administer a shock to the patient. according to the manufacturer, the rechargeable battery pack for meducore easy (wm 40150) is not affected and can continue to be used without restriction. the users are advised to take the following actions: replace battery packs with serial numbers below 20000 with a new battery pack; ensure that they carry an alternative replacement device when on professional duty (emergency service) until they receive a replacement battery pack; and if the device displays the fault described above when they are on duty, continue first-aid measures in line with erc guideline 2015 product replacement is on-going. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-13-february-17-february-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 february 2017.

Device

Battery pack for MEDUCORE Easy

Manufacturer

WEINMANN Emergency Medical Technology