FDA Adverse Event
Malfunction
Summary report: N
990.
MDR report key: 3042650
·
Received April 2, 2013
Report
- Report Number
- 1720753-2013-04497
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Date of Event
- March 18, 2013
- Report Date
- April 2, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 BOARDS AND CONNECTORS WERE RESEATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM HAD CORRUPT DATA/IMAGES AND THE CASE WAS ABANDONED. THIS ISSUE WHERE THE IMAGES/DATA ARE NOT OPTIMAL OR TRUNCATED FIELD OF VIEW CAN CAUSE THE SYSTEM TO BECOME UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135303 | 990. | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |