FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2021880
·
Received February 25, 2011
Report
- Report Number
- 1720753-2011-01689
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE REP PERFORMED AN ON SITE INVESTIGATION. THE CIRCUIT BOARD WAS REPLACED IN THE HARD DRIVE. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM MONITOR DISPLAYED A SQUARE SHAPED MARK THAT KEPT FLOWING FROM LEFT TO RIGHT ACROSS THE SCREEN AND THE SYSTEM FAILED TO BOOT UP PROPERLY. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |