FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3860933
·
Received April 14, 2014
Report
- Report Number
- 1720753-2014-03217
- Event Type
- Malfunction
- Date Received
- April 14, 2014
- Date of Event
- March 25, 2014
- Report Date
- April 14, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE FFB WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM HAD INTERMITTENT COMMUNICATION ERRORS AND THAT THE TECHS WOULD HAVE TO REBOOT THE SYSTEM TO RESTORE ITS FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228480 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |