Events

Rappel de Device Recall HeartStart MRx Defibrillator/Monitor with QCPRTM

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 Healthcare Inc..

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
    55612
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2293-2010
  • Date de mise en oeuvre de l'événement
    2010-05-06
  • Date de publication de l'événement
    2010-08-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91334
  • 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
    Reduced sensitivity in the force measurement sensor can result in inaccurate feedback to the user on how well he or she is releasing pressure after each chest compression. this can result in incomplete release of chest compression, which will reduce cpr effectiveness.
  • Action
    Philips issued an "Urgent Medical Device Recall notification/Field Safety Notice" dated April 2010 to all consignees. The letter described the issue, how to identify affected devices, and required actions. The consignees were instructed to remove affected devices from service. Philips will contact consignees to arrange on-site replacement of affected meters with meters containing revised labeling and calibration software. The new meters will indicate that meter recalibration is required after approximately 50,000 compression cycles. Consignees returning devices to Philips for routine recalibration will receive free replacement. All CPR meters will be replaced with re-designed meters when they become available. For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.

Device

Device Recall HeartStart MRx Defibrillator/Monitor with QCPRTM
  • Modèle / numéro de série
    M3535A/M3536A HeartStart MRx 453564145481 MRx Q-CPR meter 861444, MRx Q-CPR Meter Upgrade 989803162401, MRx Replacement Q-CPR Meter. Lot numbers on distribution list.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution in the countries of USA, Canada, Australia, China, Germany, Iceland, India, Libyan Arab Jamahiri, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    HeartStart MRx Defibrillator/Monitor with Q-CPR || Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality of CPR. The Q-CPR option offers real time measurement and corrective feedback on the rate, depth and complete release of compressions, ventilations rate and lack of CPR activity in accordance with current CPR guidelines. The Q-CPR option is contraindicated as follows: *The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg). *The Q-CPR option is not for use when CPR is contraindicated.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA