FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3811085
·
Received March 24, 2014
Report
- Report Number
- 1720753-2014-02651
- Event Type
- Malfunction
- Date Received
- March 24, 2014
- Date of Event
- November 14, 2013
- Report Date
- March 24, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE CUSTOMER DETERMINED TO NOT ADDRESS THE REPAIR AS THEY DO NOT USE THIS SYSTEM IN THIS CAPACITY. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADD'L SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A LOSS OF VASCULAR IMAGING MODE FUNCTIONALITY. NO PT OR INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173399 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |