FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2041565
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02792
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE MONITOR WAS CALIBRATED. ALSO, THE HIGH VOLTAGE TERMINALS ON THE TUBE SIDE WERE DISASSEMBLED, CLEANED AND AERATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEMS' DISPLAYED IMAGE CUT OUT, MAKING IT NECESSARY TO REBOOT THE SYSTEM. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |