FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2182876
·
Received July 11, 2011
Report
- Report Number
- 1720753-2011-08907
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE ERRORS. THE UNIVERSAL NODE AND THE CONTROLLER PRINTED CIRCUIT BOARDS WERE REPLACED AND THE CALIBRATION FILES WERE 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 THAT DURING A CASE THE SYSTEM'S INFORMATION AND SCREEN WOULD NOT FUNCTION AS INTENDED AND THE SYSTEM WAS PRODUCING AN ALARM. NO PATIENT 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 |