FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 1961140
·
Received January 11, 2011
Report
- Report Number
- 1720753-2011-00143
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- November 30, 2010
- Report Date
- January 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CENTRAL PROCESSOR UNIT WAS REPLACED AND SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |