FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2090615
·
Received April 26, 2011
Report
- Report Number
- 1720753-2011-06561
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- March 30, 2011
- Report Date
- April 26, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE VOLTAGE WAS ADJUSTED ON THE FLUORO FUNCTIONS BOARD AND THE POWER SUPPLY, AND THE PS2 POWER SUPPLY CONNECTOR WAS RESEATED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM DISPLAYED A WHITE IMAGE ON THE LEFT SCREEN. NO PATIENT 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 |