Events

Alerta De Seguridad para automated external defibrillator heartstart fr3

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
    2014-03-07
  • Fecha de publicación del evento
    2014-03-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140307a.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 healthcare automated external defibrillator heartstart fr3 medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning automated external defibrillator (aed) heartstart fr3 with model numbers 861388 and 861389. the affected products were manufactured from may to august 2013. according to philip healthcare, heartstart fr3 2.0 device software contains a defect which, in unlikely situations, may cause a unit to indicate that it is ready for use though its battery is low. an aed running affected software may not report its low battery condition until the unit is turned on, and consequently may be unable to maintain the power needed to deliver therapy in an emergency. the manufacturer advises users of the followings: if users have an affected device, they should remove it from service. users should upgrade all affected fr3 units according to the instructions in the fr3 software upgrade kit. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 march 2014.

Device

automated external defibrillator heartstart fr3
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Healthcare Automated External Defibrillator HeartStart FR3
  • Manufacturer
    Philips Healthcare

Manufacturer

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