FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 3093455
·
Received April 26, 2013
Report
- Report Number
- 1720753-2013-05420
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 26, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE. HOWEVER, NO REPORT OF PATIENT OR STAFF INJURY WAS REPORTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN ERROR WAS DISPLAYED AND THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY X-RAY. 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 |
|---|---|---|---|---|---|---|---|
| 182139 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |