Events

Retiro De Equipo (Recall) de Philips HeartStart MRx Monitor/Defibrillators

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-2015-RN-00149-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-20
  • 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-00149-1
  • 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 mrx could reboot once in any operating mode if the following sequence occurs:1. in service mode, the status log is cleared 2. prior to exiting service mode, the mrx generates an entry in the status log.3. service mode is exited.The mrx will restart within 8 seconds. if a reboot occurs during clinical use, current device settings and patient record are retained.
  • Acción
    A software upgrade will be provided to correct the issue. Philips is advising end users that the MRx can continue to be used prior to receiving the software update. End users are advised that if the MRx reboots during clinical use, continue to treat the patient according to your organization’s protocol, reinitiating therapy if necessary.

Device

Philips HeartStart MRx Monitor/Defibrillators
  • Modelo / Serial
    Philips HeartStart MRx Monitor/DefibrillatorsUnits Affected:Model - Serial numbersM3535A: US00100100 to US00578696M3536A: US00100902 to US00576650M3536J: US00209838 to US00332675M3536M: US00500002 to US00553553M3536MC: US00500001 to US00500087M3536M2: US00554176, US00554177, US00554178M3536M5: US00500001 to US00562935M3536M6: US00554358 to US00576619ARTG 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