FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2201354
·
Received August 3, 2011
Report
- Report Number
- 1720753-2011-20671
- Event Type
- Malfunction
- Date Received
- August 3, 2011
- Date of Event
- May 13, 2011
- Report Date
- August 3, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE POWER PLUG AT THE END OF THE CABLE WAS REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S POWER PLUG NEEDED TO BE REPLACED AS THERE WAS A LOOSE GROUND CONNECTION. NO PT 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 |