Recall Z-2329-2015 ยท CBK Ventilator, Continuous, Facility Use
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
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).
| Date | Aug 14, 2015 (initiated Jul 16, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| 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. |
| Quantity | 657 units |
| 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, Sout |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131252 | PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM Covidien, Feb 24, 2014 |