FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2102016
·
Received May 18, 2011
Report
- Report Number
- 1720753-2011-07411
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 18, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE FLUORO FUNCTIONS BOARD, THE BACK PLANE, THE POWER SUPPLY, THE INTERCONNECT CABLE ASSEMBLY, AND THE SYSTEM INTERFACE BOARD WERE REPLACED. THE NODES WERE FLASHED AND RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN X-RAY DISABLED 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 |