Events

Alerta De Seguridad para HeartStart MRx monitor/defibrillators, Model M3536A

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

¿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
    2012-05-03
  • Fecha de publicación del evento
    2012-05-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120503a.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: philips heartstart mrx monitor/defibrillators, model m3536a the medicines and healthcare products regulatory agency, united kingdom posted a field safety notice concerning all heartstart mrx monitor/defibrillators (model m3536a) with software versions r.01.00, r.02.00 or r.03.01. according to the manufacturer, philips healthcare, the affected devices may experience unexpected power cycling (system reboot) during device power on (startup). some devices have been observed to experience rebooting cycles for up to five minutes before the mrx stabilizes. there is a potential that therapy may be delayed. according to the local supplier, the affected devices had been distributed in hong kong and a software update will be provided to address the issue. if you are in possession of the affected product, please contact your supplier for necessary actions. posted 03 may 2012.

Device

HeartStart MRx monitor/defibrillators, Model M3536A
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillators, Model M3536A
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH