Events

Alerta De Seguridad para heartstart mrx defibrillator/monitor m3536a and m3535a

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

¿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
    2017-03-17
  • Fecha de publicación del evento
    2017-03-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170317.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 medical systems heartstart mrx defibrillator/monitor m3536a and m3535a health canada has issued a medical device safety alert concerning heartstart mrx defibrillator/monitor [model number: m3536a and m3535a; all lots], manufactured by philips medical systems. the manufacturer has become aware of the following issues: if the pins that connect the battery to the device have become damaged or full of debris, the device may not power on or may repetitively reboot. when the device is unplugged from ac mains, it may enter a state where it will not charge for shock delivery or may unexpectedly cease pacing. for details, please refer to the health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2017/62658r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 march 2017.

Device

heartstart mrx defibrillator/monitor m3536a and m3535a
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Medical Systems HeartStart MRX Defibrillator/Monitor M3536A and M3535A
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH