FDA Adverse Event
Malfunction
Summary report: N
9400
MDR report key: 1375827
·
Received February 25, 2009
Report
- Report Number
- 1720753-2009-01723
- Event Type
- Malfunction
- Date Received
- February 25, 2009
- Date of Event
- January 28, 2009
- Report Date
- February 25, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THE GE SERVICE REP SET THE ENTRANCE DOSE RATE TO 4.5 R/MIN IN NORMAL FLUORO MODE AND 18 R/MIN IN BOOST MODE. THE SYS FUNCTIONS AS INTENDED.
Description of Event or Problem · 1
THE GE SERVICE REP DISCOVERED THAT THE ENTRANCE DOSE RATE WAS ABOVE LIMITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9400 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |