FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1040738
·
Received May 9, 2008
Report
- Report Number
- 1720753-2008-21356
- 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
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE SERVICE REP ORDERED A VIDEO CONTROLLER PCB. THE SERVICE REP INSTALLED THE VIDEO CONTROLLER AND FINISHED THE CALL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM HAD A HORIZONTAL LINE PATTERN ON THE MONITOR. THE CASE WAS COMPLETE BUT SYSTEM WAS NOT USED THE REST OF THE DAY. 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 |