Events

Rappel de Device Recall HeartStart MRx Monitor/Defibrillator

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Electronics North America Corporation.

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
    79982
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2035-2018
  • Date de mise en oeuvre de l'événement
    2018-05-03
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164128
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    The mrx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. failure to charge could potentially cause therapy to be interrupted or delayed.
  • Action
    On May 3, 2018, the firm issued an Urgent Amended Medical Device Correction notice to affected customers via certified mail. Customers were reminded that they were previously notified in April 2016 regarding the same issue. At that time, the firm committed to providing a replacement for all affected MRx units. The May 2018 notification was sent only to remaining customers who had not yet received a replacement device. Those customers were informed that due to the product being discontinued, their affected units would receive a replacement therapy board instead of a replacement unit. Customers were informed that they could continue to use their MRx prior to repair. But, if they observe a red X in the Ready for Use indicator, to follow the troubleshooting instructions in the MRx IFU. They were also advised that they would be contacted by Philips to schedule the repair of the device. If the customer has already returned their unit but has not yet received a replacement, they were advised that Philips will be replacing the therapy board, not the entire device. If you need further information or support concerning this notification, please contact your local Philips representative or call the firm at 1-800-722- 9377.

Device

Device Recall HeartStart MRx Monitor/Defibrillator
  • Modèle / numéro de série
    US00588464, US00588657, US00589878, US00591080, US00593861
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.
  • Description du dispositif
    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) || Product Automated external defibrillators (non-wearable) || Product Usage: || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Adresse du fabricant
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA