FDA Adverse Event
Malfunction
Summary report: N
LITHIUM ION BATTERY MODULE
MDR report key: 4232406
·
Received October 23, 2014
Report
- Report Number
- 1218950-2014-06360
- Event Type
- Malfunction
- Date Received
- October 23, 2014
- Report Date
- September 29, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K110825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CONSUMER REPORTED THE MACHINE IS NOT SWITCHING ON WITH BATTERY. THERE WAS NO REPORTED PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 674424 | LITHIUM ION BATTERY MODULE | MKJ | PHILIPS MEDICAL SYSTEMS | 989803167281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |