Events

Rappel de Device Recall BIS BILATERAL SENSOR

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 Nellcor Puritan Bennett Inc. (dba Covidien LP).

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
    60372
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0802-2012
  • Date de mise en oeuvre de l'événement
    2011-11-08
  • Date de publication de l'événement
    2012-01-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105262
  • 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
    Electrode, cutaneous - Product Code GXY
  • Cause
    During manufacture, circuit traces were reversed which causes inaccurate display of information.
  • Action
    Covidien sent an Urgent Medical Device Recall letter dated November 8, 2011, to all affected customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to segregate and return any product with the affected lot numbers according to the directions provided. If product was further distributed, the recall was to be continued to those customers. Further information is available at 800-635-5267.

Device

Device Recall BIS BILATERAL SENSOR
  • Modèle / numéro de série
    Lot numbers: 0528111A, 0603111A, 0604111A, 0606111A, 0607111A, 0608111A, 0609111A, 0615111A, 0620111A, 0621111A, 0624111A, 0625111A, 0627111A, 0701111A, 0707111A, 0712111A, 0713111A, 0725111A, 0726111A, 0726111B, 0727111A, 0727111B, 0728111A, 0728111B, 0729111A, 0729111B, 0801111A, 0808111A, 0809111A, 0810111A, 0811111A, 0812111A, 0813111A, 0814111A, 0820111A, 0821111A, 0822111A, 0822111B, 0823111A, 0823111B, 0824111A, 0824111B, 0825111A, 0825111B, 0826111A, 0826111B, 0921111A, 0923111A, 0923111B, 0924111A, 0926111A, 0927111A, 0930111A, 1001111A, 1003111A, 1004111A, 1005111A, 1006111A.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: AZ, CA, CO, FL, GA, IL, KY, KS, LA, MA, MO, MS, NC, NM, NY, OH, PA, SD, TN, TX, UT, VA, WA, WI, WV and WY.
  • Description du dispositif
    BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. || Product Usage: || To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.
  • Manufacturer
    Nellcor Puritan Bennett Inc. (dba Covidien LP)

Manufacturer

Nellcor Puritan Bennett Inc. (dba Covidien LP)
  • Adresse du fabricant
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA