FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3172008
·
Received June 10, 2013
Report
- Report Number
- 1720753-2013-06914
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- May 29, 2013
- Report Date
- June 10, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SINGLE BOARD COMPUTER WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM HAD VERTICAL LINES ON THE MONITOR. THE FSE NOTED THE SYSTEM WOULD NO LONGER BOOT UP AND THE DEBUG MONITOR SHOWED A FATAL FRAME SYNC ERROR. THERE IS NO REPORT OF PT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261653 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |