FDA Adverse Event
Malfunction
Summary report: N
FLUOROSCOPIC X-RAY
MDR report key: 905973
·
Received August 30, 2007
Report
- Report Number
- 1720753-2007-04922
- Event Type
- Malfunction
- Date Received
- August 30, 2007
- Date of Event
- June 28, 2007
- Report Date
- August 30, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. IDENTIFIED THE NEED TO REPLACE THE CPU. INSTALLED CPU UPGRADE KIT, REL. 29 SOFTWARE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9800 SYSTEM KEYBOARD INTERMITTENTLY LOCKS UP. THE SYSTEM ALSO DISPLAYED ERROR CODES AND LOCKED UP WHEN SENDING IMAGES TO MDR CD BURNER. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |