Puritan Bennett 980 Series Ventilator (2020-10-21)
- Starting date:
- October 21, 2020
- Posting date:
- November 6, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74259
Last updated:
2020-11-04
Affected Products
Puritan Bennett 980 Series Ventilator
Reason
Medtronic is releasing a software update, R7.1, for all models of Puritan Bennett 980 (PB980) Series Ventilators. The software will optimize the battery pack charge voltage level to improve overall battery pack reliability, alert and direct users to replace battery packs if a faulty battery cell contained within the battery pack is detected and alert users when a battery pack is past its useful-life or within 90 days of its end-of-usefullife. This software is being released in response to in-house lab observations and customer reports of overheating and/or thermal damage to the battery pack.
Affected products
Puritan Bennett 980 Series Ventilator
Lot or serial number
All lots.
Model or catalog number
- 980S1ENDICU
- 980S1FRDICU
- 980S3ENDICU
- 980U1ENDICU
- 980U1FRDICU
- 980U3ENDICU
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES