FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3902175
·
Received February 24, 2014
Report
- Report Number
- 1720753-2014-01750
- Event Type
- Malfunction
- Date Received
- February 24, 2014
- Date of Event
- February 7, 2014
- Report Date
- February 24, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THE SYSTEM DISPLAYED A COMMUNICATION ERROR. THIS ERROR MAY RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN SITUATION DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURRED. 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 |
|---|---|---|---|---|---|---|---|
| 114391 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |