FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2040381
·
Received February 15, 2011
Report
- Report Number
- 1720753-2011-02246
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ONSITE INVESTIGATION. ALL VIDEO CONNECTIONS WERE REPAIRED INCLUDING THE POWER CONNECTION TO THE CCD CAMERA. THE SYS WAS TESTED AND IS NOW OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9600 SYS WOULD NOT FLUORO. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |