FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1040784
·
Received May 9, 2008
Report
- Report Number
- 1720753-2008-21364
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 29, 2008
- Report Date
- May 7, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE SERVICE REP AT FIRST SUSPECTED A BAD INTERCONNECT CABLE OR HIGHVOLTAGE CABLE (BROKEN VIDEO WIRE). HE THEN DETERMINED SYSTEM HAD BAD IMAGE PROCESSOR PCB. (OLD STYLE IP) WOULD REQUIRE COMPLETE UPGRADE. CUSTOMER DID NOT WANT TO SPEND MONEY TO REPAIR. CLOSE CALL SYSTEM NOT REPAIRED. LEFT UNIT DOWN AND TAGGED DO NOT USE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED NO IMAGE ON MONITOR. NO PT 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 |