FDA Adverse Event
Malfunction
Summary report: N
AC POWER MODULE
MDR report key: 2031744
·
Received March 21, 2011
Report
- Report Number
- 1218950-2011-00751
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Report Date
- March 1, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THE AC POWER MODULE HAD FAILED AND THAT THE INLET HAD PULLED OUT EXPOSING THE WIRES. THERE WAS NO REPORT OF PT INVOLVEMENT. THE LOCAL PHILIPS RESPONSE CENTER DETERMINED THAT THE MODULE HAD FAILED. THE CUSTOMER WAS SHIPPED A NEW ONE WHICH RESOLVED THE FAILURE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE AC POWER MODULE HAD FAILED AND THAT THE INLET HAD PULLED OUT EXPOSING THE WIRES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AC POWER MODULE | MKJ | PHILIPS HEALTHCARE | M3539A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |