Events

Retiro De Equipo (Recall) de HeartStart XL Defibrillator Battery / Monitor, model M3516A (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-2012-RN-00993-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-09-26
  • 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-2012-RN-00993-1
  • 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
    If the xl defibrillator/monitor (m4735a) is used on a patient when ac power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
  • Acción
    Customers are being advised to identify whether they are using the defibrillators with a defective battery and to operate the affected HeartStart XL Defibrillator/Monitor using AC power supply only. Philips will be providing affected customers with a replacement battery(s) as soon as a new production of batteries are available.

Device

HeartStart XL Defibrillator Battery / Monitor, model M3516A (manual defibrillator).
  • Modelo / Serial
    HeartStart XL Defibrillator Battery / Monitor, model M3516A (manual defibrillator).Units Affected: HeartStart XL battery M3516A labelled with 'Made in Taiwan' and date of manufacture 'R-2011-12'ARTG 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