FDA Adverse Event
Malfunction
Summary report: N
9600+
MDR report key: 1173001
·
Received September 19, 2008
Report
- Report Number
- 1720753-2008-26100
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- September 2, 2008
- Report Date
- September 19, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP BOOTED THE MACHINE, AND IT FUNCTIONED PROPERLY. HE RESEATED ALL BOARDS IN THE WORKSTATION, CLEANED THE FAN FILTER AND DUSTED INSIDE THE EMI BOX. THE REP RAN THE SYSTEM AND TESTED ALL FUNCTIONS. SYSTEM FUNCTIONS AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THEY FINISHED ONE CASE AND WENT TO START A SECOND WHEN THE IMAGE ON THE MONITOR STARTED ROLLING. THEY MADE FLUORO, AND THE IMAGE CONTINUED TO ROLL. THEY REBOOTED THE MACHINE, AND THE MONITORS CAME UP ALL WHITE. THE CUSTOMER COMPLETED THE CASE WITH ANOTHER C-ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600+ | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |