Events

Rappel de HeartStart MRx Defibrillator/Monitor

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
    51673
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1390-2009
  • Date de mise en oeuvre de l'événement
    2009-04-10
  • Date de publication de l'événement
    2009-06-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80929
  • 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
    Spontaneous turn-on which could deplete the battery, rendering the device unusable until power is restored. there is also the possibility of a failure mode in which the device fails to respond to user initiated turn-on, rendering it unusable for monitoring and therapy.
  • Action
    Philips notified customers via Urgent Medical Device Recall Letter & Notice dated March 2009. Customers are asked to follow the "Actions to be taken by customer/user section of the Urgent Medical Device Recall Notice. In this section, customers are given the following instructions: "During the interim period, as you await the upgrade for your device, you may continue to use the Heartstart MRx. However, to reduce the risk that a spontaneous turn-on could deplete the battery, it is advised that you keep: a charged spare battery with the Heartstart MRx AC power applied, if possible, when the device is not in use You should also consider identifying a readily available backup defibrillator to use in the unlikely event that the device fails to turn on. Devices that exhibit a spontaneous turn-on or failure to respond to user initiated turn on should be removed from service as soon as possible." Philips will replace the therapy switch in affected units free of charge per Mandatory Field Change Order FC086100077. All customers will be contacted by a Philips Healthcare representative to arrange for replacement of the therapy switch in the affected devices.

Device

HeartStart MRx Defibrillator/Monitor
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Afghanistan, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Oman, Panama, Papua, New Guinea, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudia Arabia, Serbia & Montenegro, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
  • Description du dispositif
    HeartStart MRx Defibrillator/Monitor, M3535A/M3536A || Is used 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 basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • 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