FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE NIMH BATTERY
MDR report key: 2934691
·
Received December 21, 2012
Report
- Report Number
- 3003793491-2012-00581
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 20, 2012
- Report Date
- November 23, 2012
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT YET RECEIVED THE DEVICE ASSOCIATED WITH THIS REPORT. HOWEVER, THE DEVICE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING USE, THE BATTERY DIED IN APPROXIMATELY 5 MINUTES. SECOND BATTERY DIED AFTER APPROXIMATELY 10 MINUTES. CUSTOMER ALSO REPORTED THAT THE BATTERIES WERE TEST CYCLED EVERY MONTH.
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 |