FDA Adverse Event
Malfunction
Summary report: N
PROTEUS XR/A
MDR report key: 1334723
·
Received February 26, 2009
Report
- Report Number
- 9613445-2009-00014
- Event Type
- Malfunction
- Date Received
- February 26, 2009
- Date of Event
- February 12, 2009
- Report Date
- February 12, 2009
- Manufacturer
- GE HANGWEI MEDICAL SYSTEMS CO., LTD.
- Product Code
- KPR
- PMA / PMN Number
- K993090
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE FIELD ENGINEER (FE) FOUND THAT THE FLAG IN ONE OF THE FOOT PEDAL ASSEMBLY WAS NOT FULLY SEATING INTO THE OPTICAL SENSOR, PREVENTING THE TABLE LOCKS FROM ENGAGING. THE FE ADJUSTED THE FLAG AND VERIFIED THAT TABLE LOCKS WERE PERFORMING AS EXPECTED.
Description of Event or Problem · 1
IT WAS REPORTED THE TABLE LOCKS WERE NOT ACTUATING, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THE ISSUE WAS DISCOVERED DURING POWER-UP. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PATIENT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTEUS XR/A | KPR | GE HANGWEI MEDICAL SYSTEMS CO., LTD. | 2259988 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |