Events

Rappel de Philips Xper Flex Cardio Patient Monitoring Systems Revisions A and B

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00643-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00643-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA