FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1151083
·
Received September 9, 2008
Report
- Report Number
- 1720753-2008-24770
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 4, 2008
- Report Date
- August 15, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP REPLACED THE POWER SUPPLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VERTICAL COLUMN INTERMITTENTLY DOES NOT GO UP OR DOWN. CUSTOMER HAS ANOTHER C-ARM THAT THEY ARE ABLE TO USE. NO PATIENT INJURY TO REPORT.
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 |