FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1070305
·
Received July 9, 2008
Report
- Report Number
- 1720753-2008-20559
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 10, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND DETERMINED THE SNUBBER BOARD CAUSED THE FAULT. THE GE REP PLACED THE SNUBBER BOARD ON ORDER. IT IS ANTICIPATED THAT REPLACEMENT OF THIS PART WILL RESTORE THE SYSTEM TO OPERATING AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THERE WAS NO IMAGE ON THE MONITOR. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |