Device product
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
Z-1652-2013
Product summary
- Firm
- BRAEMAR, INC.
- Event
- Event 65410
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3286 packs
- Official record key
device-enforcement:Z-1652-2013
Official wording
Reason: Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact.
Code information: n/a
Distribution pattern: Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.
Derived failure modes
-
Unknown
Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact.