FDA Adverse Event
Malfunction
Summary report: N
AC POWER MODULE
MDR report key: 2170838
·
Received June 22, 2011
Report
- Report Number
- 1218950-2011-01783
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Report Date
- May 27, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE AC POWER MODULE WAS NOT WORKING AND WOULD NOT POWER UP ON AC POWER. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE UNIT WAS EVALUATED BY PHILIPS AND THE FAILURE WAS VERIFIED. REPLACEMENT OF THE AC POWER MODULE RESOLVED THE FAILURE. THE MODULE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE AC POWER MODULE WAS NOT WORKING AND WOULD NOT POWER UP ON AC POWER.
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 |