FDA Recall Open, Classified

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 980X1ENDRAC 980X1NLDRAC 980A1ENNISB 980X3TRDRAC 980X3CSNISC 980U3ESDIUC 980U1ENASAA 980X1JADIJJ 980X1FRAIQC 980X1ENDIPC 980X1ENNISB 980X1ESDIEC 980X1ITDIEC 980X1PTDIPC 980X1DEDRAC 980X1TRDRAC 980X3RODRAC 980S1ENDICU 980X3RUDRAC 980U1ESDIUU 980U3ESDIUA 980X3SRDRAC 980X1ENDIPP 980U1ESDIUC 980X3ENDIUU 980X3ENDIJI 980X1SKNISC 980X3PTDIPC 980U1ESDIUA 980U3PTDIUNA 980X1DAAGAC 980X1FIAGAC 980X1NOAGAC 980X1SVAGAC 980X3ENAIQC 980X1HUNISC 980X2ENDIUU 980X3ENASAA 980X1ENASAA 980S3ESDIUU 980X1RODRAC 980S1PTDIUNA 980X1SLDRAC 980S1ESDIUU 980S1ESDIUC 980S3ESDIUA 980S1ESDIUA 980S3ESDIUC 980S1FRDICU 980S3ENDICU 980X2ENASAA 980X2ITDIEC 980X1ELAIQC 980X2DEDRAC 980X2FRAIQC 980X2ENNISB 980X2ESDIEC 980A2ENNISB 980X2PLDIPC 980X1ENAIQC 980U1PTDIUNA 980X3ENDISS 980X2ENDISS 980X1HRDRAC 980X3RUDIEC 980U3ENDICU 980X1SRDRAC 980X1ENDIJI 980X2RUDRAC 980X3ENDIPB 980P1ZHNISD 980P3ZHNISD 980C1ZHNISD 980C3ZHNISD 980C2ZHNISD 980N1ZHNISD 980N3ZHNISD 980P2ZHNISD 980X1ENNISC 980U3ENDIUU-LA 980U1ENDIUU-LA

Recall: Z-0425-2021 · Initiated October 16, 2020

Recall

Recall Number: Z-0425-2021
Event Number: 86643
Firm: Covidien Llc
FEI Number: 1282497
Product Code: CBK
Status: Open, Classified
Root Cause: Device Design
Initiated: October 16, 2020
Address: 15 Hampshire St, Mansfield, MA, 02048-1113

Description

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,

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 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

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, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Taiwan, Korea, Brunei Daruss., Cambodia, Indonesia, Malaysia, Singapore, Thailand, Vietnam, Japan.

Quantity

23,329 units total:. US 12,956; OUS 10,405