FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1021757
·
Received March 19, 2008
Report
- Report Number
- 1720753-2008-19784
- Event Type
- Malfunction
- Date Received
- March 19, 2008
- Date of Event
- March 6, 2008
- Report Date
- March 18, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. RESEATED A PIN IN THE LEMO RECEPTACLE CABLE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERMITTENTLY THE KVP AND MA WOULD GO TO MAX ON THE 9800 SYSTEM AND THE IMAGE ON THE LEFT HAND MONITOR GOES WHITE. THE CASE WAS COMPLETED AND THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |