FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE NIMH BATTERY
MDR report key: 3173451
·
Received May 28, 2013
Report
- Report Number
- 3003793491-2013-00624
- Event Type
- Malfunction
- Date Received
- May 28, 2013
- Date of Event
- May 3, 2013
- Report Date
- May 3, 2013
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- PMA / PMN Number
- K112998
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED. PLEASE SEE RELATED MFR REPORT #3003793491-2013-00623 FOR AUTOPULSE NIMH BATTERY WITH SN (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO AUTOPULSE NIMH BATTERIES KEPT FAILING IN THE CHARGER AND THAT THEY WOULD NOT HOLD CHARGE. NO ADVERSE PT SEQUELAE WAS REPORTED. MANUFACTURER REQUESTED ADDITIONAL INFO FROM THE CUSTOMER; HOWEVER NO INFO WAS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233389 | AUTOPULSE NIMH BATTERY | AUTOPULSE NIMH BATTERY | DRM | ZOLL CIRCULATION, INC. | 8700-0702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |