Rappel de NeoMode software used on Puritan Bennett 980 Series (PB980) Universal Ventilator System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien Pty Ltd.

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    There have been 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 recognised. there have been no serious injuries or deaths related to these reports. covidien’s investigation has identified a software anomaly that contributes to this volume delivery issue in neonatal vc+ mode. this issue has not been observed during neonatal pressure control ventilation, or with paediatric or adult modes of ventilation.
  • Action
    Covidien will develop and implement a software update for the universal models of ventilators with NeoMode capability. Until that time, Covidien will disable the clinician’s ability to use NeoMode in the PB980 ventilator. A service engineer will be in contact with hospitals to coordinate this process.


  • Modèle / numéro de série
    NeoMode software used on Puritan Bennett 980 Series (PB980) Universal Ventilator SystemARTG Number: 221416
  • Classification du dispositif
  • Manufacturer


  • Société-mère du fabricant (2017)
  • 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