FDA Adverse Event
Malfunction
Summary report: N
AC POWER MODULE
MDR report key: 1983700
·
Received February 3, 2011
Report
- Report Number
- 1218950-2011-00300
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Report Date
- January 6, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IT WAS REPORTED TO PHILIPS THAT THE AC INLET WAS PULLED OUT OF THE AC POWER MODULE AND THE WIRES WERE BROKEN. A PHILIPS INVESTIGATOR SPOKE WITH THE CUSTOMER WHO REPORTED THAT THE AC POWER MODULES HAVE BEEN REPLACED AND THAT THE UNITS ARE BACK IN USE AT THE CUSTOMER SITE.
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS THAT THE AC INLET WAS PULLED OUT OF THE AC POWER MODULE AND THE WIRES WERE BROKEN.
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 |