FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 1970097
·
Received January 14, 2011
Report
- Report Number
- 1720753-2011-00303
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 17, 2010
- Report Date
- January 14, 2011
- 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 THE SOFTWARE AND CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM LOCKED UP AND FAILED TO SAVE PT IMAGES. NO REPORT OF PT IMAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |