Events

Alerta De Seguridad para Carry Case used with the HeartStart FR3 Automated external defibrillator (AED)

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
    2012-03-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120306a.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
    Field safety notice: carry case used with the heartstart fr3 automated external defibrillator (aed) the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning the carry case used with heartstart fr3 aed, manufactured by philips healthcare. according to the manufacturer, the heartstart fr3 aed itself is not part of this action. only the small soft carry cases [model numbers 989803173711 (philips) and 989803173721 (laerdal)] manufactured by philips and shipped between may 2011 and august 2011 are part of this action. all small soft cases, models 989803173711and 989803173721, are affected. the model number can be found on the carry case label, located directly under the fr3 when it is stored in the case. the affected small soft carry cases incorporate a magnet in the lid that automatically turns the fr3 aed on when the case is opened. if the case is not aligned properly when closed, the fr3 may interpret the resulting intermittent misalignment of the magnet as a case opening. thus, the aed may turn on repeatedly while stored in the case, inadvertently depleting the battery. the manufacturer warned users that a drained battery may not allow the fr3 to deliver therapy in case of an emergency. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm according to the local supplier, the affected device has not been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Carry Case used with the HeartStart FR3 Automated external defibrillator (AED)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Carry Case used with the HeartStart FR3 Automated external defibrillator (AED)
  • Manufacturer
    Philips Healthcare

Manufacturer

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