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 980X1PLDIPC 980X3SKNISC 980U3ESDIUU 980X1DEDISS 980X3DEDISS 980X3HUNISC 980X3ENDIPP 980X1BGDRAC 980 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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,

Recommended Action

Per FDA guidance

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 information. Adhere to the instructions described in the PB980 Series Ventilator Operators Manual and battery addendum for Li-Ion Battery Pack Handling, Storage, and Replacement. Promptly dispose of battery packs that are faulty or have reached their end-of-useful-life, according to local regulations. informs customers of the release of software update, R7.1, for all models of Puritan Bennett" 980 (PB980) series ventilators. Actions being taken by Medtronic Medtronic developed a software update, R 7.1. This software release is available for installation. For all warranty and service contract customers, Medtronic Service will load the R 7.1 software during your next scheduled or planned maintenance visit. For those customers outside of warranty or not on an active service agreement, when your response form is received Medtronics Service Team will contact you to set up a time to perform the update In addition, Medtronic made modifications to the PB980 Series Ventilator Operators Manual. The manual has been updated with additional information for users regarding the new software update. The revised manual can be accessed at: https://www.medtronic.com/covidien/en-us/support/product-manuals.html Questions, please contact our Technical Support Department at 1-800-255-6774