FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 4240017
·
Received November 3, 2014
Report
- Report Number
- 1720753-2014-09108
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- October 14, 2014
- Report Date
- November 3, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A COMMUNICATION ERROR MESSAGE AND HUNG UP. IT IS LIKELY THE CUSTOMER EXPERIENCED A SYSTEM LOCKUP SITUATION WHICH WAS RESOLVED FOLLOWING A REBOOT. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703895 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |