FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9900
MDR report key: 1151064
·
Received September 9, 2008
Report
- Report Number
- 1720753-2008-24761
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- July 30, 2008
- Report Date
- August 15, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE BATTERY PACK, POWER CAP MODULE, AND THE GIB. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED A CHANNEL 3 FAIL ERROR CODE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |