FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 3832986
·
Received March 25, 2014
Report
- Report Number
- 9680959-2014-00398
- Event Type
- Malfunction
- Date Received
- March 25, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 25, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERMITTENTLY THE MONITOR POWER WOULD LOOSE POWER. THIS COULD CAUSE THE SYSTEM TO BECOME UNUSABLE DUE TO THE INABILITY TO PRODUCE LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173775 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |