FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1980106
·
Received January 24, 2011
Report
- Report Number
- 1720753-2011-00536
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- January 3, 2011
- Report Date
- January 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE, FLUORO FUNCTIONS BOARD, AND THE GENERATOR INTERFACE BOARD WERE REPLACED 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
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM COLLIMATOR IRIS CLOSED DOWN ON ITS OWN DURING A CASE. THE PROCEDURE WAS COMPLETED. NO PATIENT 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 |