Events

Retiro De Equipo (Recall) de LifePak CR Plus and LifePak Express Automatic External Defibrillators

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-2016-RN-01044-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-08-18
  • 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-2016-RN-01044-1
  • 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 an issue whereby the lifepak plus aed or lifepak express aed may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. the device will turn on and complete the initialisation steps, however , there are no voice prompts provided to the user and the device will enter standby mode. after 15 seconds in standby, the device will switch off. a defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. all reports received from customers have been noted during initial set up and testing of the device. to date, there have been no patient related events.
  • Acción
    Physio-Control is providing users with instructions to follow to identify the affected units: · Open the lid and listen for voice prompts within 5 seconds - If the voice prompts are properly activated, press and hold the ON/OFF button for 2 seconds to turn the device off. Continue to monitor your device(s) per your established routine check process until contacted by Physio-Control to arrange component replacement for all affected serial numbers. - If voice prompts are not activated, please remove the device from service and contact Physio-Control at 1 800 890 892 to arrange for device correction. Users are advised to continue to monitor the device(s) per established routine check process until contacted by Physio-Control to arrange component replacement for all affected serial numbers.

Device

LifePak CR Plus and LifePak Express Automatic External Defibrillators

Manufacturer

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