FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2971779
·
Received February 6, 2013
Report
- Report Number
- 1720753-2013-01493
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- January 25, 2013
- Report Date
- February 6, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN OVER-THE-PHONE INVESTIGATION. THE CUSTOMER WAS INSTRUCTED TO RESET THE CB2 CIRCUIT BREAKER. THE SYSTEM WAS THEN OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A POWER FAILED ERROR MESSAGE AND SHUT DOWN WITHOUT COMMAND. AFTERWARD THEY WERE UNABLE TO BOOT UP THE SYSTEM. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51488 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |