FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 4110646
·
Received September 16, 2014
Report
- Report Number
- 1720753-2014-07931
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- August 26, 2014
- Report Date
- September 16, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE WAS EVALUATED AND AN IMPROPER CONNECTION WAS REPAIRED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE FLUOROSCOPIC IMAGE WAS WHITED OUT EFFECTIVELY ELIMINATING THE ABILITY TO VIEW A USABLE IMAGE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572176 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |