FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 4180644
·
Received October 15, 2014
Report
- Report Number
- 1720753-2014-08672
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 26, 2014
- Report Date
- October 15, 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 REP EVALUATED THE SYSTEM BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS NOT AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS LOUD NOISE AND A GENERATOR ERROR. THE FIELD ENGINEER NOTED THAT THE SYSTEM WAS ARCING. THE SYSTEM AUTOMATICALLY SHUTS DOWN WHEN THIS OCCURS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653730 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |