FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 1910006
·
Received November 10, 2010
Report
- Report Number
- 1720753-2010-04015
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 25, 2010
- Report Date
- November 10, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE WAS REFORMATTED AND SOFTWARE RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE TABLE DISPLAYED A MOTION ERROR CODE MESSAGE. NO REPORT OF PT OR STAFF INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |