FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 914943
·
Received September 18, 2007
Report
- Report Number
- 1720753-2007-05637
- Event Type
- Malfunction
- Date Received
- September 18, 2007
- Date of Event
- August 13, 2007
- Report Date
- September 4, 2007
- Manufacturer
- GE OEC MEDICAL INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE CROSS ARM BRAKE ASSEMBLY. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CROSS ARM BRAKE IS BROKEN. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUROSCOPIC X-RAY | JAA | GE OEC MEDICAL INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |