FDA Adverse Event
Malfunction
Summary report: N
APIX TABLE
MDR report key: 2042980
·
Received March 25, 2011
Report
- Report Number
- 1720753-2011-02855
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- February 25, 2011
- Report Date
- March 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- KXJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SVC REP PERFORMED AN ON-SITE INVESTIGATION. THE SVC REP REPLACED THE HAND CONTROLLER, THE INTERIOR TABLE CONSOLE CABLE AND THE TABLE CONSOLE. THE APIX TABLE WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE APIX TABLE WOULD NOT MOVE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APIX TABLE | RADIOLOGIC TABLE | KXJ | GE OEC MEDICAL SYSTEMS (SLC) | APIX TABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |