FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3960220
·
Received June 24, 2014
Report
- Report Number
- 1720753-2014-05395
- Event Type
- Malfunction
- Date Received
- June 24, 2014
- Date of Event
- April 8, 2014
- Report Date
- June 23, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AG
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. A SYSTEM REPAIR WAS DETERMINED TO BE REQUIRED, HOWEVER 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 THAT THE SYSTEM EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367326 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |