FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2994200
·
Received February 13, 2013
Report
- Report Number
- 1720753-2013-01760
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- February 5, 2013
- Report Date
- February 13, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE X-RAY TUBE AND BATTERY PACK WERE REPLACED AND THE GENERATOR WAS CALIBRATED DURING THE SERVICE CALL. 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 THE SYSTEM DISPLAYED A "KV ON IN ERROR" MESSAGE. THIS ERROR IS LIKELY TO RESULT IN UN-COMMANDED LOSS OF SYSTEM FUNCTIONALITY AND REQUIRE A SYSTEM REBOOT. THERE IS NOT REPORT OF PT INJURY PR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63979 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |