FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE NIMH BATTERY
MDR report key: 2983187
·
Received January 31, 2013
Report
- Report Number
- 3003793491-2013-00263
- Event Type
- Malfunction
- Date Received
- January 31, 2013
- Date of Event
- July 24, 2012
- Report Date
- August 9, 2012
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
REPORTED COMPLAINT OF "BATTERY FAILED TEST CYCLE" WAS CONFIRMED. BATTERY FAILED 10 SECONDS AFTER IT WAS PLACED IN THE CHARGER. FOR THIS REASON, BATTERY DATA COULD NOT BE ACCESSED. NO ADVERSE EVENT REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE AUTOPULSE BATTERY S/N'S (B)(4) DID NOT PASS THE TEST CYCLE ON THE AUTOPULSE CHARGER AND ARE NOT USABLE. NO ADVERSE EVENT REPORTED. BATTERY SN (B)(4), MFR REPORT# 3003793491-2013-00261; BATTERY SN (B)(4), MFR REPORT# 3003793491-2013-00262; BATTERY SN (B)(4), MFR REPORT# 3003793491-2013-00263.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43725 | AUTOPULSE NIMH BATTERY | NIMH BATTERY | DRM | ZOLL CIRCULATION, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |