FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 1913573
·
Received November 12, 2010
Report
- Report Number
- 1720753-2010-04041
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 14, 2010
- Report Date
- November 12, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER CABLE WAS REPAIRED DURING THE SERVICE CALL. THE SYSTEM WAS FOUND TO BE WORKING AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 6800 SYSTEM WOULD NOT TURN ON. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |