FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2994153
·
Received February 13, 2013
Report
- Report Number
- 1720753-2013-01729
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- January 24, 2013
- Report Date
- February 13, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS AN INTERLOCK FAILURE ERROR MESSAGE. THIS ERROR MAY CAUSE THE SYSTEM TO SHUT DOWN UNCOMMANDED. 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 |
|---|---|---|---|---|---|---|---|
| 63194 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |