Events

Retiro De Equipo (Recall) de Meducore Easy Automatic External Defibrillator (AED) - Battery Pack

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por USL Medical Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00281-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-05-02
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00281-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    An issue has been identified that in rare cases, the meducore easy battery pack may fail. in the event of failure, it would no longer be possible to administer a shock to the patient, which could lead to unsuccessful resuscitation.
  • Acción
    USL Medical will be providing users with a replacement battery. Once the replacement battery is received, users are to immediately remove and discard the affected battery and insert the new battery into the device. Whilst waiting on the replacement battery, USL Medical recommends close monitoring of the status indicators on the front of the Meducore Easy AED to ensure battery and device readiness.

Device

Meducore Easy Automatic External Defibrillator (AED) - Battery Pack
  • Modelo / Serial
    Meducore Easy Automatic External Defibrillator (AED) - Battery PackBattery Pack Model Number: WM 40155Serial Numbers: 15120, 15122, 15127, 15121, 15119, 15126, 15118, 15117, 15116 & 15128ARTG Number: 214662
  • Manufacturer
    USL Medical Pty Ltd

Manufacturer

USL Medical Pty Ltd