Events

Retiro De Equipo (Recall) de LIFEPAK 15 Monitor/Defibrillator

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Physio-Control Australia 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-00102-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-23
  • 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-00102-1
  • 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
    Physio-control has become aware of a potential device issue where the lifepak 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (relay) installed on the therapy printed circuit board assembly (pcba). a malfunction of the relay can be identified during the user test of the device. if the user test fails, the device will illuminate the service indicator icon on the device. if the user test passes, the device is safe to use.
  • Acción
    Physio-Control is contacting customers with LIFEPAK 15 devices that contain the potentially affected Relay component to arrange for a device correction. This correction will include the replacement of the Therapy PCBA. If needed, loaner devices will be made available while the repairs are being made. In the interim, users are advised to continue to perform the User Test as outlined in the Daily Operator’s Checklist within the LIFEPAK 15 Operating Instructions. If the device fails the User Test, contact Physio-Control immediately to arrange for correction of the device. This action has been closed-out on 25/05/2017.

Device

LIFEPAK 15 Monitor/Defibrillator

Manufacturer

Physio-Control Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA