FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1992799
·
Received February 4, 2011
Report
- Report Number
- 1720753-2011-00904
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 14, 2011
- Report Date
- February 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND RETAPPED THE ISOLATION TRANSFORMER TO ACCOMMODATE THE CUSTOMER'S ELECTRICAL POWER SUPPLY. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT WHEN SETTING UP THE C-ARM FOR A CASE, THE WORKSTATION BEGAN ALARMING WHEN IT WAS PLUGGED INTO THE WALL POWER OUTLET. THE SYSTEM WOULD NOT BOOT UP, AND DISPLAYED A HIGH CAPACITY DISK 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 |