Events

Retiro De Equipo (Recall) de Philips HeartStart XL+ Defibrillator / Monitor (manual 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 Philips Electronics Australia 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-2013-RN-00156-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-19
  • 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-2013-RN-00156-1
  • 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
    The philips heartstart xl+ defibrillator/monitor may fail to power on in clinical mode and instead power on in service mode, displaying an "equipment disabled: therapy" prompt, requiring the user to enter a password and perform an operational check to clear the condition. the device will not return to clinical mode until an operational check has been performed.
  • Acción
    A Philips representative with contact customers with affected devices to arrange for a software update. Until the correction is implemented the device can continue to be used by following work around procedures.

Device

Philips HeartStart XL+ Defibrillator / Monitor (manual defibrillator)
  • Modelo / Serial
    Philips HeartStart XL+ Defibrillator / Monitor (manual defibrillator)Model Number: 861290Serial Number ranges:USO1100100–USO1100372US61201722–US61201924USN1100376–USN1100960US71201925–US71202048USD1100961–USD1101095US81202049–US81202168US11201096–US11201186US91202169–US91202514US21201187–US21201239USO1202515–USO1202990US31201240–US31201537USN1202991–USN1203537US41201538–US41201585USD1203538–USD1203968US51201586–US51201721US11303969–US11303972
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA