FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2884840
·
Received December 3, 2012
Report
- Report Number
- 1720753-2012-09913
- Event Type
- Malfunction
- Date Received
- December 3, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 30, 2012
- 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 ON SITE INVESTIGATION. A QUOTE WAS ISSUED TO THE CUSTOMER FOR THE REPAIR. NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE CINE FUNCTION WAS NOT WORKING PROPERLY. RESULTING IN A LOSS OF SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |