FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2062049
·
Received April 6, 2011
Report
- Report Number
- 1720753-2011-03274
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 24, 2011
- Report Date
- April 6, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SEATING OF ALL CONNECTORS AND PRINTED CIRCUIT BOARDS WAS VERIFIED AND THE VOLTAGE FOR THE WORKSTATION AND VIDEO CONTROLLER PRINTED CIRCUIT BOARD WAS MEASURED TO BE ADEQUATE. THE PROBLEM WAS NOT ABLE TO BE DUPLICATED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 6800 SYSTEM INTERMITTENTLY WOULD NOT BOOT UP PRIOR TO A CASE. THE CUSTOMER POWERED DOWN THE SYSTEM AND RESTARTED IT W/O FURTHER BOOT UP ISSUES. 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 |