Events

Rappel de Device Recall Infinity Delta/Gamma X XL Portable 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 Draeger Medical Systems, 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
    55870
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2283-2010
  • Date de mise en oeuvre de l'événement
    2010-06-04
  • Date de publication de l'événement
    2010-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92106
  • 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
    Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) - Product Code MHX
  • Cause
    Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. this may discharge a patient automatically.
  • Action
    Draeger Medical issued "Urgent-Medical Device Recall Notification" letters to affected consignees. The Delta/Gamma X XL monitor keyboards will be updated with new material at each affected facility. If the keys on affected monitors become inoperative or activate without user interaction, the customer is instructed to remove the monitor from service and contact Draeger at 978-379-8573. A Technical Service Bulletin (TSB) will be distributed globally, instructing subsidiaries to inform international customers.

Device

Device Recall Infinity Delta/Gamma X XL Portable Monitor
  • Modèle / numéro de série
    Catalog Number: MS18597
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - United States, including the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, ME, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WO, and W, and the countries of United Arab Emirates, Angola, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Benin, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Serbia, Czech Republic, Germany, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Coratia, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Jordan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon,Lithuania, Latvia, Libya, Morocco, Macedonia, Martinique, Mexico, Netherlands, Norway, Nepal, Peru, Poland, Puerto Rico, Portugal, Qatar, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovak Republic, Turkmenistan, Turkey, Ukraine, Uruguay, Venezuela, Mayotte and South Africa. The government accounts are Bay Pines VAMC, Bay Pines, FL; Naval Medical Center, Portsmouth, VA; and Walter Reed Army Medical Center, Washington, DC.
  • Description du dispositif
    Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
  • Manufacturer
    Draeger Medical Systems, Inc.

Manufacturer

Draeger Medical Systems, Inc.
  • Adresse du fabricant
    Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Société-mère du fabricant (2017)
    Stefan Dräger GmbH
  • Source
    USFDA