FDA Adverse Event
Malfunction
Summary report: N
7600
MDR report key: 1241678
·
Received November 19, 2008
Report
- Report Number
- 9680959-2008-00218
- Event Type
- Malfunction
- Date Received
- November 19, 2008
- Date of Event
- October 30, 2008
- Report Date
- November 17, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP VERIFIED THE SYMPTOM. HE FOUND A PROBLEM WITH THE INTERCONNECT CABLE. HE RECEIVED AND INSTALLED THE NEW CABLE THEN PERFORMED A FUNCTION CHECK, AND THE SYSTEM PERFORMED AS DESIRED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS NO IMAGE ON THE LEFT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |