Events

Rappel de Philips Heartstart MRx Monitor/Defib

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 Philips Medical Systems (USA).

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
    13427
  • Date de mise en oeuvre de l'événement
    2012-08-31
  • 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: Laerdal (New Zealand) Ltd, Unit O, Cain Commerical Centre, 20 Cain Road, Penrose
  • Cause
    Certain heartstart mrx monitor/defibrillators were manufactured with compromised components within the time frames of july 12, 2011 through september 2, 2011 and january 19, 2012 through may 22, 2012., may present the folowing behaviours:, a. in aed mode the mrx experiences difficulty interpreting pads ecg waveforms and may incorrectly analyze the waveform (potential for inappropriate therapy) or fail to anlyze the waveform., b. in manual mode the user may have trouble interpreting the pads ecg waveform and determining whether or not to deliver therapy. in addition the mrx may provide erroneous alarms or indicate an asystolic rhythm when paddles are not in patient cntact., c. if cpr meter is in use, users may not get an accurate impedance derived ventilation feedback.
  • Action
    Product to be modified

Device

Philips Heartstart MRx Monitor/Defib

Manufacturer

Philips Medical Systems (USA)
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA