Recall Z-0425-2021 ยท CBK Ventilator, Continuous, Facility Use
Covidien Llc
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980X3PLDIPC 980X3ESDIEC 980X3ITDIEC 980X3JADIJJ 980X3SVAIQC 980U3ENASAA 980U1ENDICU 980U1FRDICU 980X3ENDRAC 980X1FRDISS 980A3ENNISB
| Date | Oct 16, 2020 |
| Status | Open, Classified |
| Reason | In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm, |
| Root cause | Device Design |
| Action | Medtronic issued Urgent Medical Device Correction letter to consignees via Federal Express and/or certified mail beginning October 16, 2020. The letter states reason for recall, health risk and action to take: Immediately notify all care environments in which the PB980 series ventilators are used about this letter. If the facility has distributed PB980 series ventilators to other persons or facilities, consignees are directed to promptly forward a copy of the letter to those recipients. Complete the response form and return it as directed to confirm receipt and understanding of the informat |
| Quantity | 23,329 units total:. US 12,956; OUS 10,405 |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Argentina, Bolivia, Brazil, Cayman Islands, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Jamaica, Mexico, Nicaragua, Panama, Peru, Uraguay, Honduras, Austria, Bahrain, Belgium, Bulgaria, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162738 | Puritan Bennett 980 Ventilator System Covidien, Oct 27, 2017 |