Events

Alerta De Seguridad para HeartStart FR2+ M3860A, M3861A, M3840A and M3841A

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

¿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
    2010-06-01
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20100603.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
    Press release
  • Causa
    Recall of automated external defibrillators the department of health (dh) today (june 1) drew public attention to a voluntary recall by the philips electronics hong kong ltd. of four models of automated external defibrillators (aeds) which may have voltage detector problems. the affected models are heartstart fr2+ m3860a, m3861a, m3840a and m3841a. investigation conducted by the manufacturer revealed that the units may contain a component called a voltage detector from lots that have a higher than expected rate of failure, which can cause the aed battery to drain more rapidly than normal or to render the aed unusable. according to philips electronics hong kong ltd, a total of 46 units of the affected models of aeds have been sold to clinics, medical professional organisations and commercial organisations and the company has alerted its purchasers. those who possess the affected models should contact the company by calling its hotline 2876 7578 for advice. dh has not received any report of adverse incidents arising from this issue and will work closely with the company to monitor the recall. 1 jun 2010.

Device

HeartStart FR2+ M3860A, M3861A, M3840A and M3841A

Manufacturer

Philips Electronics Hong Kong Ltd.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH