Events

Rappel de Device Recall Puritan Bennett 840 Ventilator

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
    68444
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1844-2014
  • Date de mise en oeuvre de l'événement
    2014-06-03
  • Date de publication de l'événement
    2014-06-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127717
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Cause
    Covidien is conducting a medical device field correction for specific puritan bennett 840 ventilators due to customer reports of loss of graphical user interface (gui) display information while the ventilator continues to provide breath support.
  • Action
    Covidien sent an Urgent Medical Device Voluntary Field Correction letter dated 6/13/2014, to all affected customers. The letter identified the product the problem and and the action needed to be taken by the customer. Customers are requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Service professionals will be identifying the affected PSUs and replacing them. The removed PSUs will be destroyed. To verify whether your devices are affected by this field safety corrective action and to initiate the process to receive the actions mentioned above, please complete the attached verification form and fax it to the Covidien contact indicated on the form. If you need further assistance, contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1.

Device

Device Recall Puritan Bennett 840 Ventilator
  • Modèle / numéro de série
    serial number 3510100714 to 3512101160 and any units in which a replacement PSU was installed between March 2010 and September of 2010.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, Germany, Guatemala, Israel, Japan, Kazakhstan, Kenya, Lebanon, Libya, Macedonia, Mexico, Montenegro, Morocco, Panama, Peru, Russia, Saudi Arabia, Singapore, Switzerland, Taiwan, Tunisia, Turkey, Yugoslavia (Serbia & Montenegro) Including GOVT/VA/Military
  • Description du dispositif
    Puritan Bennett 840 Ventilator (4-840120DIUU-XX) || The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.
  • 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