Events

Rappel de Philips IntelliVue Patient Monitors

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-2016-RN-01025-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-04
  • 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-2016-RN-01025-1
  • 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
    If an affected patient monitor has been powered on continuously for several months, any displayed waveforms will contain out-dated data and therefore fail to reflect the patient’s current condition. even if out-dated waveforms are displayed as a result of this problem, the monitor’s alarms and numeric displays of vital signs will continue to function as specified and accurately reflect current patient data. the length of time that a monitor must be powered on before the problem occurs depends on the selected wave speed. it ranges from 102 days (@50 mm/s) to 820 days (@ 6,25 mm/s), and is approximately 205 days at the monitor’s default wave speed of 25 mm/s. the monitor must be powered off in order to avoid this problem. simply placing it in stand-by mode is not sufficient. please note that connected devices, such as central monitors continue to display the correct wave data.
  • Action
    Philips Healthcare is advising users to cycle the power on the affected devices on a monthly basis. A software upgrade will be implemented as a permanent correction.

Device

Philips IntelliVue Patient Monitors
  • Modèle / numéro de série
    Philips IntelliVue Patient MonitorsModel Numbers: MX400, MX430, MX450, MX500, MX550Product Codes: 866060, 866061, 866062, 8066064, 866066ARTG Number: 213953
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA