Events

Rappel de Device Recall Puritan Bennett 980 Ventilator System Universal and Neonatal Models

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 Covidien LP (formerly Nellcor Puritan Bennett 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
    71675
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2329-2015
  • Date de mise en oeuvre de l'événement
    2015-07-16
  • Date de publication de l'événement
    2015-08-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138678
  • 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
    Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal volume control plus (vc+) mode with active humidification. this situation may potentially lead to respiratory compromise if not recognized.
  • Action
    Consignees will be notified via letter on July 17, 2015. No products will be returned, the reconfiguration of affected ventilators will occur at customer sites.

Device

Device Recall Puritan Bennett 980 Ventilator System Universal and Neonatal Models
  • Modèle / numéro de série
    PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey, and Uruguay.
  • Description du dispositif
    Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. || Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
  • Manufacturer
    Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Manufacturer

Covidien LP (formerly Nellcor Puritan Bennett Inc.)
  • Adresse du fabricant
    Covidien LP (formerly Nellcor Puritan Bennett Inc.), 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