Events

Retiro De Equipo (Recall) de Philips HeartStart XL+ Defibrillator/Monitor

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-2014-RN-00477-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-28
  • 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-2014-RN-00477-1
  • 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
    A software communication failure on the heartstart xl+ that occurs during an automated ready-for-use test or at turn-on may lock the user out of clinical mode, which may delay therapy. the communication error can trigger a false failure condition - error code 1:34 "equipment disable: therapy". if the user is locked out of clinical mode, a delay in therapy may occur, which could pose a risk for patients.
  • Acción
    Philips is providing a software update to correct the issue. End users are advised while awaiting the software upgrade for the affected device users may continue to use the HeartStart XL+ unless the device exhibits a Red X, presents an audio chirp and displays the user message: “Equipment Disabled: Therapy”. This is an indicator that the device self-test has detected the problem and is not ready for use. In the case the problem cannot be resolved by running Op-Check, users should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits the communication failure. This action has been closed-out on 01/02/2016.

Device

Philips HeartStart XL+ Defibrillator/Monitor
  • Modelo / Serial
    Philips HeartStart XL+ Defibrillator/MonitorModel Number: 861290.Units upgraded to B.00.01 software, or manufactured by Philips between December, 2013 and February, 2014Multiple serial numbers affectedARTG Number: 95661
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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