FDA Adverse Event
Malfunction
Summary report: N
BATTERY 14.8V, 6.3 AH LI-LON BATTERY
MDR report key: 3981297
·
Received June 20, 2014
Report
- Report Number
- 1218950-2014-03606
- Event Type
- Malfunction
- Date Received
- June 20, 2014
- Report Date
- May 30, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE BATTER WAS NOT DETECTED IN THE MRX OR CADEX BATTERY CHARGER AND WAS DEPLETED. THERE WAS NO REPORTED PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364316 | BATTERY 14.8V, 6.3 AH LI-LON BATTERY | MKJ | PHILIPS MEDICAL SYSTEMS | M3538A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |