FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2081052
·
Received April 14, 2011
Report
- Report Number
- 9680959-2011-01063
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 17, 2011
- Report Date
- April 14, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. NO PT OR STAFF INJURY WAS REPORTED. THIS EVENT COULD BE A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 7700 SYSTEM DISPLAYED A HIGH KILOVOLT ERROR MESSAGE. 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 |