FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1002750
·
Received February 26, 2008
Report
- Report Number
- 1720753-2008-16402
- 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
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. BASED ON INFO PROVIDED THE FOLLOWING COMPONENTS HAVE BEEN ORDERED. DISK DRIVE, SINGLE BOARD COMPUTER, SYSTEM SOFTWARE, FLUORO FUNCTION PCB AND GENERATOR INTERFACE PCB. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENTS ARE REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADD'L 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 IMAGE WENT DARK AND DISPLAYED "LIVE" ON THE SCREEN WHEN NOT FLUORING. REBOOT WAS REQUIRED TO GET SYSTEM TO WORK. 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 | NI |