FDA Adverse Event
Malfunction
Summary report: N
AC POWER MODULE
MDR report key: 2250950
·
Received August 31, 2011
Report
- Report Number
- 1218950-2011-02583
- Event Type
- Malfunction
- Date Received
- August 31, 2011
- Report Date
- August 4, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THE AC POWER MODULE CONNECTOR PULLED OUT AND WIRES ARE EXPOSED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE AC POWER MODULE WAS NOT AVAILABLE FOR EVALUATION. THE AC POWER MODULE WAS REPLACED TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE AC POWER MODULE CONNECTOR PULLED OUT AND WIRES ARE EXPOSED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AC POWER MODULE | MKJ | PHILIPS HEALTHCARE - ANDOVER | M3539A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |