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-00209-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-25
  • 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-00209-1
  • 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
    An internal component on the heartstart xl power board may malfunction potentially affecting the ability to deliver therapy. specifically, the xl may be unable to charge and deliver a shock. in addition, when used for external pacing, the malfunction may result in a loss of capture.
  • Acción
    Philips will be installing replacement power boards to correct the problem. A Philips representative will be in contact with customers to make arrangements for the correction. While awaiting the replacement power board for the device, users may continue to use the HeartStart XL. Identify a readily available backup defibrillator to use in the event the affected HeartStart XL fails to deliver therapy. This action has been closed-out on 11/02/2016.

Device

Philips HeartStart XL, Defibrillator/Monitor
  • Modelo / Serial
    Philips HeartStart XL, Defibrillator/MonitorModel Number: M4735AUnits Affected: Units manufactured by Philips between May, 2013 and November, 2013 Serial numbers within the range: US00101665 to US00608704
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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