FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2041406
·
Received March 23, 2011
Report
- Report Number
- 1720753-2011-02659
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED A TELEPHONE CONSULTATION. THE SINGLE BOARD COMPUTER WAS RESEATED AND THE CMOS OPERATING SYSTEM SETTINGS WERE RESET. RECOMMENDATIONS WERE GIVEN TO RESEAT THE CINE BRIDGE PRINTED CIRCUIT BOARD AND THE CINE DRIVE AND TO CONTACT SERVICE IF THIS DID NOT PRODUCE A POSITIVE RESULT. NO CONCLUSION CAN BE DRAWN AS ADDITIONAL REPAIR INFORMATION IS UNAVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 6800 SYSTEM WOULD NOT BOOT UP AND PRODUCED A 'NO FRAME SYNCHRONIZATION' ERROR. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |