FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3963028
·
Received June 23, 2014
Report
- Report Number
- 1720753-2014-05336
- Event Type
- Malfunction
- Date Received
- June 23, 2014
- Date of Event
- June 6, 2014
- Report Date
- June 20, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE CINE HARD DISK DRIVE WAS EVALUATED AND IDENTIFIED AS REQUIRING REPLACEMENT. THE CUSTOMER DECLINED FURTHER SERVICE. 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 DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 366073 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |