FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2062103
·
Received April 6, 2011
Report
- Report Number
- 1720753-2011-03304
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 24, 2011
- Report Date
- April 6, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE RTOS SINGLE BOARD COMPUTER AND THE HARD DRIVE, AND RELOADED SYSTEM SOFTWARE AND CONFIGURATION FILES. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WILL NOT BOOT UP. 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 |