FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1992798
·
Received February 4, 2011
Report
- Report Number
- 1720753-2011-00906
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 14, 2011
- Report Date
- February 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE ORBITAL AND ROTATIONAL POTENTIOMETER CABLES, SERVO MOTOR DRIVES, GENERATOR INTERFACE BOARD, AND THE PS1 POWER SUPPLY. ADJUSTED GENERATOR +5 VOLTS POWER SUPPLY TO 5.15 VOLTS, AND PERFORMED A MOTION CALIBRATION. DURING SERVICE, NOTED THAT THE MANUAL CLUTCH RELEASE MECHANISM HAD LOOSE SCREWS. REPAIRED CLUTCH MECHANISM. REPLACED THE REMOTE USER INTERFACE (JOYSTICK) CONSOLE. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE C-ARM MOVEMENT JOYSTICK LOCKED UP DURING A PROCEDURE AND WOULD NOT MOVE THE C-ARM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |