FDA Adverse Event
Malfunction
Summary report: N
BATTERY 14.8V, 6.3 AH LI-ION BATTERY
MDR report key: 2910638
·
Received December 4, 2012
Report
- Report Number
- 1218950-2012-03970
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Report Date
- November 30, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4), THE CUSTOMER REPORTED THAT THE BATTERY WILL CHARGE, BUT IS NOT RECOGNIZED BY THE DEVICE. THERE WAS NO REPORT OF PT INVOLVEMENT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ON (B)(6) 2012, THE CUSTOMER REPORTED THAT THE BATTERY WILL CHARGE BUT IS NOT RECOGNIZED BY THE DEVICE. THERE WAS NO REPORT OF PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BATTERY 14.8V, 6.3 AH LI-ION BATTERY | MKJ | PHILIPS MEDICAL SYSTEMS | M3538A | 12152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |