Events

Retiro De Equipo (Recall) de Philips Xper Flex Cardio Patient Monitoring Systems Revisions A and B

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-2018-RN-00643-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-05
  • 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-2018-RN-00643-1
  • 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
    Philips have identified an intermittent communication issue between the host system and the flex cardio (fc). it is possible for any of the following conditions to occur, which could result in delays in diagnosis or treatment:- boom monitor may not display all active waveform and/or vital sign data- delayed audible and visual alarms at the fc and boom monitor respectively, due to a mismatch between the alarm limits on the host system and the fc/boom monitor- after patient admission and case initiation at the host system, the case may not be fully transmitted to the fc. in this case, the boom monitor in the exam/procedure room will display vital sign data, but the fc will not provide audible alarms- after patient discharge and case termination at the host system, case termination may not be transmitted to the fc. in this case, the boom monitor in the exam/procedure room will continue to display vital sign data, and the fc will continue to provide audible alarms.
  • Acción
    Philips are advising the following to reduce the probability of intermittent communication issues: - The Flex Cardio must communicate with its host system via an isolated, dedicated Ethernet port - Do not turn the Flex Cardio device on and/or off while a patient case is open - Verify that the patient name is visible on the Boom Monitor, which is an indication that the patient case has fully transferred and audible alarms are active. Also, if all expected vital signs are not displayed on the Boom Monitor, close and then re-open the case to resynchronize the Flex Cardio and the host system. An addendum to the device’s Instructions for Use will be provided to all affected customers by a Philips representative. Philips will also review the contents of the Instructions for Use addendum with each customer and confirm understanding of the addendum’s contents. Affected customers will also be provided with an updated Software and Documentation Media Kit, which contains the IFU addendum.

Device

Philips Xper Flex Cardio Patient Monitoring Systems Revisions A and B
  • Modelo / Serial
    Philips Xper Flex Cardio Patient Monitoring SystemsRevisions A and BAffected devices have at least one of the following numbers on its back: Service # 453564241901 and 453564483321ARTG Number: 229631(Philips Electronics Australia - Patient monitor system)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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