FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3871814
·
Received April 17, 2014
Report
- Report Number
- 1720753-2014-03358
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 31, 2014
- Report Date
- April 17, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE FILAMENT DRIVER PCB 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 THERE WAS A STATOR NOT ON ERROR MESSAGE. THIS ERROR WILL LIKELY CAUSE THE SYSTEM TO SHUT DOWN UN-COMMANDED, WHICH WOULD RESULT IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236201 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |