FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3860935
·
Received April 14, 2014
Report
- Report Number
- 1720753-2014-03214
- 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
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE GIB, FFB, SYSTEM INTERFACE AND SBC BOARDS WERE EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE SYSTEM HAD A COMMUNICATION ERROR WHICH CAUSED THE SYSTEM TO REBOOT ITSELF. THIS CAUSED AN INTERMITTENT RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228451 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |