FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 3822769
·
Received February 7, 2014
Report
- Report Number
- 1720753-2014-01278
- Event Type
- Malfunction
- Date Received
- February 7, 2014
- Date of Event
- January 22, 2014
- Report Date
- February 7, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- 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 REPORTED ISSUE COULD NOT BE DUPLICATED. THE CPU BOARD WAS REPLACED DURING SERVICE. THE HARD DRIVE WAS REFORMATTED AND THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM SHOWED A BY PASSIBLE ERROR MESSAGE; HOWEVER WHEN THE CUSTOMER TRIED TO BYPASS THE ERROR, THE SYSTEM LOST ITS FUNCTIONALITY. THERE IS NO REPORTS OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80852 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |