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
    155048
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-11-07
  • 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 of three (3) issues that could impact the safety and/or performance of certain mrx monitor/defibrillators: issue 1: the heartstart mrx defibrillator/monitor can be susceptible to interference from electrical fast transients (efts) when connected to ac or dc power operating with a lan cable or operating near a source of eft interference which could cause therapy to be delayed or delivered inadvertently. issue 2: if a user performs one of two atypical clinical workflows the heartstart mrx defibrillator/monitor can exhibit unexpected behaviour. these workflows do not correspond to instructions in the heartstart mrx defibrillator/monitor instructions for use and are not expected to be performed by trained clinicians. in addition these device behaviours have only been observed during internal testing and have not been reported during clinical use. the workflows and associated device behaviors are as follows: workflow a: when using external paddles for defibrillation the device can deliver a shock when only one of the two shock buttons are depressed if the user performs a specific sequence. workflow b: when using the periodic clinical data transmission (pcdt) option on the mrx the mrx can reboot if the user performs a specific sequence. issue 3: the heartstart mrx defibrillator/monitor could stop demand mode pacing due to an ecg leads-off condition when electrode-to-skin contact impedance values are outside design ranges for detection.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Modèle / numéro de série
    Model Catalog: M3535A (Lot serial: ALL); Model Catalog: M3536A (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