Events

Retiro De Equipo (Recall) de Philips HeartStart MRx Defibrillator/MonitorMRx unit types with software versions F.03.06 (M3535A) and T.00.05 (M3536A) and earlier

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-01079-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-06
  • 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-01079-1
  • 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
    Mrx model m3535a and model m3536a may stop the automated ready-for-use (rfu) test in an abnormal state when the device is turned off. if this occurs, the rfu indicator window displays a pattern that is not documented in the instructions for use (ifu) or service manual. if this pattern appears and the device is turned on, it will revert the rfu back to an hourglass, indication that it is fully functional in all monitoring and therapy modes. there is no clinical risk if the device that has displayed this rfu pattern is turned on and put into service. a device experiencing this issue will continue to run automated rfu test hourly and report a 0x00c000a4 code in the status log summary each time.
  • Acción
    All MRx users should be informed that if the pattern appears, they can continue to use the device. Once the MRx is turned on, the pattern will disappear and the device will function normally in all monitoring and therapy modes. Philips will provide a software upgrade – for M3535A (software version F.03.07 or higher) and M3536A (software version T.00.06 or higher) – to correct this issue. A software upgrade will be provided free of charge for all affected products. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades.

Device

Philips HeartStart MRx Defibrillator/MonitorMRx unit types with software versions F.03.06 (M3535A...
  • Modelo / Serial
    Philips HeartStart MRx Defibrillator/MonitorMRx unit types with software versions F.03.06 (M3535A) and T.00.05 (M3536A) and earlier Part Numbers: M3535A, M3535ATZ, M3536A, M3536ATZ, M3536J, M3536M, M3536M2, M3536M4, M3536M5, M3536M6, M3536MCARTG Number: 261352
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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