Events

Rappel de Philips Xper Flex Cardio Physiomonitoring System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Invivo, a division of Philips Medical Systems.

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
    23017
  • Date de mise en oeuvre de l'événement
    2018-05-24
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    A problem has been detected in the xper flex cardio patient monitoring system, it is possible for any of the following conditions to occur, which could result in delays in diagnosis or treatment:, 1. boom monitor (display) may not display all active waveform and/or vital sign data., 2. delayed audible and visual alarms at the flex cardio and boom monitor respectively, due to a mismatch between the alarm limits on the host system and the flex cardio/boom monitor., 3. after patient admission and case initiation at the host system, the case may not be fully transmitted to the flex cardio.
  • Action
    Instructions for use to be updated

Device

Philips Xper Flex Cardio Physiomonitoring System

Manufacturer

Invivo, a division of Philips Medical Systems
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA