FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1993269
·
Received February 7, 2011
Report
- Report Number
- 1720753-2011-01060
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 24, 2011
- Report Date
- February 7, 2011
- 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
GE REP EVALUATED THE SYSTEM AND REPLACED THE FLUORO FUNCTIONS BOARD AND GENERATOR INTERFACE BOARD, RELOADED CALIBRATION FILES AND RETAPED THE ISOLATION TRANSFORMER TO MATCH INCOMING VOLTAGE. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE SYSTEM LOCKED UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |