FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2090531
·
Received April 26, 2011
Report
- Report Number
- 1720753-2011-06526
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 26, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE PROBLEM. THE NODES WERE FLASHED AND THE SYSTEM FILES REBUILT. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 6800 SYSTEM DISPLAYED AN ERROR MESSAGE THAT THE MAXIMUM DOSE HAD BEEN REACHED AND CONTRACT SETTINGS NEEDED TO BE ADJUSTED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |