FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2031277
·
Received March 16, 2011
Report
- Report Number
- 1720753-2011-02387
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 25, 2011
- Report Date
- March 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. PARTS WERE ORDERED. ANOTHER GE SERVICE REPRESENTATIVE PERFORMED ON SITE REPAIRS. THE HARD DRIVE, MOTHERBOARD, PRINTER SERVICE BOARD AND THE IMAGE PROCESSOR WERE REPLACED. THE SOFTWARE WAS REINSTALLED AND THE SYSTEM CONFIGURATION RELOADED. THE SYSTEM AND FLUORO WERE TESTED AND THEY OPERATE AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9600 SYSTEM WORKSTATION WOULD NOT COMPLETE THE BOOT UP PROCESS. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |