FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1002741
·
Received February 26, 2008
Report
- Report Number
- 1720753-2008-16411
- Event Type
- Malfunction
- Date Received
- February 26, 2008
- Date of Event
- February 19, 2008
- Report Date
- February 26, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. BASED ON INFO PROVIDED THE FOLLOWING COMPONENT HAS BEEN ORDERED. A 24V POWER SUPPLY. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENT IS REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADDITIONAL INFO IS RECEIVED THAT INDICATES OTHERWISE, A FOLLOWUP REPORT WILL BE SUBMITTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9800 SYSTEM C-ARM VERTICAL COLUMN WILL NOT RAISE. IT WAS NOTED THAT THE DOWN BUTTON WORKS INTERMITTENTLY AND THE MONITOR SCREEN IS GOING DARK. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |