FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1973628
·
Received January 19, 2011
Report
- Report Number
- 1720753-2011-00399
- Event Type
- Malfunction
- Date Received
- January 19, 2011
- Date of Event
- December 24, 2010
- Report Date
- January 19, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE HARD DRIVE, POWER CABLE, AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM HAD A CORRUPT FILE ERROR PRIOR TO A CASE. NO PATIENT 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 |