FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3770002
·
Received January 28, 2014
Report
- Report Number
- 1720753-2014-00939
- Event Type
- Malfunction
- Date Received
- January 28, 2014
- Date of Event
- January 20, 2014
- Report Date
- January 28, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT X-RAYS STAY ON AFTER RELEASING THE X-RAY SWITCH. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62223 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |