Events

Rappel de HEARTSTART MRX DEFIBRILLATOR/MONITOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHILIPS ELECTRONICS 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
    91530
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-11-21
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Philips has become aware that the heartstart mrx defibrillator/monitor may contain incorrect internal software settings causing the following two (2) issues: 1. the device will perform the weekly automated tests hourly which could cause the therapy capacitors to degrade sooner than intended. 2. while connected to ac or dc power and with no battery installed or the battery installed has a charge level of less than 10% the ready for use (rfu) indicator will not provide the expected low battery indication (flashing red x with audible chirp). instead the rfu will show a flashing black hourglass indicating that sufficient battery power is available for device operation. note: once the device is disconnected from ac or dc power the rfu indicator provides the appropriate low battery indications. in addition all other battery charge indicators continue to operate normally including the onscreen battery fuel gauges low battery messages and low battery alarms. the led charge level indicators on the batteries themselves also operate normally.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Modèle / numéro de série
    Model Catalog: M3536A (Lot serial: ALL); Model Catalog: M3535A (Lot serial: ALL)
  • Description du dispositif
    HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC