FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE NIMH BATTERY
MDR report key: 2935819
·
Received January 2, 2013
Report
- Report Number
- 3003793491-2012-00705
- Event Type
- Malfunction
- Date Received
- January 2, 2013
- Date of Event
- November 2, 2012
- Report Date
- November 2, 2012
- Manufacturer
- ZOLL CIRCULATION INC
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ZOLL HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONGOING LOW RUN TIME ISSUE WITH THE BATTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1610 | AUTOPULSE NIMH BATTERY | NIMH BATTERY | DRM | ZOLL CIRCULATION INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |