FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2994150
·
Received February 13, 2013
Report
- Report Number
- 1720753-2013-01717
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- January 30, 2013
- Report Date
- February 13, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND ADJUSTED THE 5 VOLT POWER SUPPLY. THE CUSTOMER WILL REPLACE THE HARD DRIVE. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO WAS NOT REPORTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS TAKING A LONG TIME TO BOOT UP AND UPON REBOOT, A FILES CORRUPTED ERROR MESSAGE WAS DISPLAYED. THE FIELD ENGINEER NOTED THAT THE SYSTEM WOULD NOT BOOT UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63654 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |