Events

Alerta De Seguridad para HeartStart MRx/MRxE M3535A and HeartStart XL M4735A

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
    2009-04-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20090425.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 (april 24) alerted the public of a voluntary recall by the manufacturer of two models of automated external defibrillator (aed) which have switch problem. the affected models are heartstart mrx/mrxe m3535a and heartstart xl m4735a. investigation conducted by the manufacturer, philips healthcare, revealed that failures are more likely to occur in devices that have been exposed to high heat and humidity, which contribute to accelerated internal degradation of switch components over time. about 270 aed of the two models have been introduced to hong kong, mostly to public and private hospitals. philips healthcare has alerted its purchasers. people should not use the aed of the affected models and contact the company by calling its hotline 2876 7578 for advice. dh has not received any report of adverse events arising from this issue and will closely monitor the recall. ends.

Device

HeartStart MRx/MRxE M3535A and HeartStart XL M4735A
  • Modelo / Serial
  • Descripción del producto
    Press release: Recall of Automated External Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

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