FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 1910007
·
Received November 10, 2010
Report
- Report Number
- 1720753-2010-04014
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 20, 2010
- Report Date
- November 10, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR WAS DISASSEMBLED AND REPAIRED, THEN CALIBRATED. THE REMOTE UTILITY SUITE WAS ACCESSED AND FILES DOWNLOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED AN ERROR CODE MESSAGE. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPY XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |