Events

Rappel de Device Recall Covidien

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
    68802
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2234-2014
  • Date de mise en oeuvre de l'événement
    2014-07-17
  • Date de publication de l'événement
    2014-08-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128766
  • 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(without arrhythmia detection or alarms) - Product Code MWI
  • Cause
    Covidien is conducting a field correction of the vital sync virtual patient monitoring platform and informatics manager due to a mismatch between the alarm priority on the medical devices and the vital sync system.
  • Action
    The firm, Covidien, sent an "URGENT FIELD CORRECTIVE ACTION NOTICE" letter dated 7/16/14 to its customers on 7/17/14 via FedEx. The letter informs users that a representative will be in contact to schedule a software update.The letter also described the product, problem and actions to be taken. The customers were instructed to disregard the audible and visual alarm priority indicators and only use the alarm description text on the patient tile and on the patient detail page for alarm priority information, until the mismatch is corrected. The Vital Sync" Virtual Patient Monitoring Platform and Informatics Manager or Vital Sync" Remote Monitoring System may still be used until the software update is available. If you have questions about this letter or to report any issues with the Vital Sync" Virtual Patient Monitoring Platform and Informatics Manager or Vital Sync" Remote Monitoring System, contact our Technical Support Department at (800)635-5267, option 3, then option 1.

Device

Device Recall Covidien
  • Modèle / numéro de série
    Model # 10007101; Lot # 14A0041IN
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
  • Description du dispositif
    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. || The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
  • 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