FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2193054
·
Received July 22, 2011
Report
- Report Number
- 1720753-2011-20318
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 15, 2011
- Report Date
- July 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP ADJUSTED THE MAINFRAME POWER SUPPLY, AND CHECKED THE WORKSTATION POWER SUPPLY, THE PRINTED CIRCUIT BOARD CONNECTION, THE INTERCONNECT CABLE, AND THE HIGH VOLTAGE CONNECTIONS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY A BLACK IMAGE ON THE MONITOR DURING FLUOROSCOPIC S-RAY. 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 |