FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2182721
·
Received July 8, 2011
Report
- Report Number
- 9680959-2011-01546
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 24, 2011
- Report Date
- July 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE FAULTY TUBE NEEDS TO BE REPAIRED OR REPLACED. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADD'L SVC INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYS WOULD NOT CAPTURE FLUOROSCOPIC IMAGES AND WAS NOT FUNCTIONING AS INTENDED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7700 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |