FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1014249
·
Received March 12, 2008
Report
- Report Number
- 1720753-2008-17921
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 26, 2008
- Report Date
- March 11, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SERVICE REP REPLACED THE IGBT SNUBBER BOARD. AFTER REPLACING SNUBBER, BOOTED SYSTEM, AND THERE WAS AN ARC UNDER THE METAL COVER OVER THE FILAMENT DRIVER BOARD AND IGBT. FOUND THE FILAMENT DRIVER BOARD BAD, REPLACED. TEST: BOOTED THE SYSTEM WITHOUT ERROR MULTIPLE TIMES, VERIFIED X-RAYS MADE. SYSTEM FUNCTIONS AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM BOOTS PROPERLY, BUT THE IMAGE ON THE LEFT MONITOR IS BLANK. SYSTEM IS NOT MAKING X-RAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |