Events

Rappel de Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors

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, 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
    60269
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0281-2012
  • Date de mise en oeuvre de l'événement
    2011-10-31
  • Date de publication de l'événement
    2011-11-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104924
  • 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
    Firm received 2 complaints reporting ventricular fibrillation (vfib) arrhythmias were not recognized by the monitor and did not alarm when the masimo set pod is used for spo2 measurements.
  • Action
    Firm initiated their recall of this device on October 25, 2011 by sending an "Urgent Medical Device Recall" letter to consignees. A Technical Service Bulletin will be generated and distributed globally that instructs the affected International Draeger subsidiaries to inform customers in their countries. The software anomaly has been corrected in software version 7.3. Draeger Service Representatives will schedule time with customers to upgrade the software in affected monitors. The software upgrade will be provided free of charge.

Device

Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors
  • Modèle / numéro de série
    Catalog Number(s): MS18597 and MS18852,  Software versions: VF6.2, VF6.3, VF6.4, VF7.1 and VF7.2
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution- USA including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WI and WV and International distribution including the countries of Algeria, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Botswana, Brasilien, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Deutschland, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Finland, France, Frankreich, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indien, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Jordanien, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Madagascar, Malaysia, Malta, Mauritius, Mayotte, Mexico, Moldavia, Moldova, Morocco, Netherlands, Norway, Norway, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Rumania, Russian Fed., Saudi Arabia, Serbia, Seychelles, Singapore, Slovenia, Slowenien, South Africa, South Korea, Spain, Sri Lanka, S¿dafrika, Sweden, Switzerland, Syria, Taiwan, Thailand, Tschechische Republic, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and White Russia.
  • Description du dispositif
    Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

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