FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2042957
·
Received March 25, 2011
Report
- Report Number
- 1720753-2011-02853
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SVC REP PERFORMED AN ON-SITE INVESTIGATION. THE SVC REP REPLACED THE FLUORO FUNCTIONS BOARD, AND RESEATED THE FUSES. THE SYS IS OPERATING AS INTENDED. THIS EVENT MAY BE AN ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYS LOCKED UP WITH THE X-RAY ON LAMP ILLUMINATED. 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 |