FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE NIMH BATTERY
MDR report key: 2932963
·
Received December 31, 2012
Report
- Report Number
- 3003793491-2012-00548
- Event Type
- Malfunction
- Date Received
- December 31, 2012
- Date of Event
- October 31, 2012
- Report Date
- October 31, 2012
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT BATTERY HAS FAILED TESTING IN THE CHARGER TWICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOPULSE NIMH BATTERY | NIMH BATTERY | DRM | ZOLL CIRCULATION, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |