FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1173004
·
Received September 19, 2008
Report
- Report Number
- 1720753-2008-26103
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- September 3, 2008
- Report Date
- September 19, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP FOUND THE CORD FRAYED NEAR ENTRANCE TO WORK STATION. HE REPAIRED THE FRAYED CORD, SO NO EXPOSED WIRES. THE UNIT IS WORKING NORMALLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE POWER CORD WAS FRAYED. NO PATIENT INJURY WAS REPORTED.
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 |