Events

Retiro De Equipo (Recall) de LifePack 1000 Automated External Defibrillator (AED's), software version 2.42 or earlier

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-2015-RN-01036-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-10-26
  • 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-2015-RN-01036-1
  • 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
    As a follow-up to the previous communication in 2014 (tga ref: rc-2014-rn-00774-1), physio-control is correcting a software malfunction that may contribute to defibrillator batteries not being replaced when required.Physio-control australia has become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock and deliver therapy.The operating instructions provided with the device may be confusing to some customers, which has contributed to customers not replacing their battery when required. also, a software malfunction in the lifepak 1000 defibrillator that also contributes to some customers not replacing their battery when required. this results in the readiness display indicating a low battery charge when it should indicate a very low battery charge.
  • Acción
    Physio-Control will be implementing a software update in all affected devices over the next year. Updates to customer devices will be prioritised based on the age of the devices as well as the feedback provided in the response to the confirmation sheet attached with the customer letter. In the interim, customers are advised that it is critically important to understand what the device and battery indicators mean on the defibrillator and what actions needs to be undertaken. At any time the battery charge can be verified by the instructions provided in the Operating Instructions. Batteries that are at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not the OK symbol is present.

Device

LifePack 1000 Automated External Defibrillator (AED's), software version 2.42 or earlier
  • Modelo / Serial
    LifePack 1000 Automated External Defibrillator (AED's), software version 2.42 or earlierAll lots affected ARTG Number: 138166
  • Manufacturer
    Physio-Control Australia Pty Ltd

Manufacturer

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