FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2223050
·
Received August 10, 2011
Report
- Report Number
- 1720753-2011-20923
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- July 26, 2011
- Report Date
- August 10, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE WAS REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE SYSTEM DISPLAYED A COMMUNICATION ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |