FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2090547
·
Received April 26, 2011
Report
- Report Number
- 1720753-2011-06553
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 26, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE FLUORO FUNCTIONS BOARD, THE SINGLE BOARD COMPUTER, THE GENERATOR INTERFACE BOARD, AND THE CELERON PRINTED CIRCUIT BOARDS AS WELL AS THE VIDEO CABLE. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM DISPLAYED A FAILED COMMUNICATION ERROR MESSAGE AND DISTORTED IMAGES. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |