FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1140695
·
Received September 3, 2008
Report
- Report Number
- 1720753-2008-24303
- Event Type
- Malfunction
- Date Received
- September 3, 2008
- Date of Event
- July 24, 2008
- Report Date
- August 5, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP ORDERED THE POWER DISTRIBUTION PCB AND SURGE SUPPRESSOR PCB. HE REMOVED AND REPLACED THE POWER DISTRIBUTION AND SURGE SUPPRESSOR PCB. THE REP RESTRAPPED THE TRANSFORMER FOR PROPER OUTPUT. THE TRANSFORMER APPEARED UNBALANCED. NOW SYSTEM IS TRIPPING CB2 INPUT BREAKER. HE ORDERED A POWER SUPPLY AND INTERCONNECT CABLE. THE INTERCONNECT HAD SEVERAL BROKEN WIRES. THE FINAL RESOLUTION WAS THE ISOLATION TRANSFORMER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SYSTEM POWER DISTRIBUTION PCB HAS FAILED 3 TIMES.
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 |