FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2073688
·
Received April 13, 2011
Report
- Report Number
- 1720753-2011-03567
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 18, 2011
- Report Date
- April 13, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE MAIN HARD DRIVE WAS REPLACED AND THE SOFTWARE AND CALIBRATION FILES WERE RELOADED. THE IMAGES WERE SAVED AND SENT TO THE PACS SYSTEM. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9900 SYSTEM DISPLAYED A HIGH CAPACITY DISC FAILURE ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |