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
    42948
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-12-16
  • 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 could reboot once in any operating mode if the following sequence occurs: 1. in service mode the status log* is cleared 2. prior to exiting service mode the device generates an entry in the status log. 3. service mode is exited. the heartstart mrx device is then in a state that could trigger a reboot at an indeterminate time potentially causing therapy to be interrupted or delayed. the heartstart mrx device will restart within 8 seconds. note: if a reboot occurs during clinical use current device settings and patient record are retained. *the status log is a tool accessed by service personnel. it includes entries for all messages logged during normal operating mode automated tests service and configuration mode and operational checks. the heartstart mrx defibrillator/monitor service manual instructs service personnel to clear the status log after successful completion of an operational check.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Modèle / numéro de série
    Model Catalog: M3536A (Lot serial: FOR MODEL M3536A:); Model Catalog: M3535A (Lot serial: FOR MODEL M3536A:); Model Catalog: M3535A (Lot serial: FOR MODEL M3535A:); Model Catalog: M3536A (Lot serial: US00100100 to US00578696); Model Catalog: M3535A (Lot serial: US00100100 to US00578696); Model Catalog: M3535A (Lot serial: US00100902 to US00576650); Model Catalog: M3536A (Lot serial: US00100902 to US00576650); Model Catalog: M3536A (Lot serial: FOR MODEL M3535A:)
  • 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