FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1151087
·
Received September 9, 2008
Report
- Report Number
- 1720753-2008-24774
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 15, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GIB PCB ASSY WAS REMOVED AND REPLACE. THE SYSTEM SOFTWARE RELOADED, A SYSTEM OP CHECKS WAS PERFORMED, AND THE GE REP ALLOWED THE SYSTEM TO REMAIN ON/IDLE AND EXPOSURES WERE TAKEN RANDOMLY DURING A 4HR TIME FRAME. HE WAS UNABLE TO DUPLICATE LOCKUP WHEN SYSTEM IN IDLE POSITION. THE YSTEM WAS RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN THE SYSTEM IS ALLOWED TO REMAIN IDLE AND THE EXPOSURE BUTTON IS DEPRESSED, THE SYSTEM FAILS TO RESPOND. IF SYSTEM IS REVOOTED, IT WORKS AS INTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |