FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9600
MDR report key: 930355
·
Received October 22, 2007
Report
- Report Number
- 1720753-2007-06661
- Event Type
- Malfunction
- Date Received
- October 22, 2007
- Date of Event
- September 26, 2007
- Report Date
- October 16, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE OEC SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE AND COULD NOT DUPLICATE THE MALFUNCTION. USER UNFAMILIAR WITH SYSTEM OPERATION. ALSO FOUND DEFECTIVE INTERCONNECT CABLE THAT WAS REMOVED AND REPLACED. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFORMATION WITH RESPECT TO THIS ISSUE. CUSTOMER IS A MEDICAL DEVICE MANUFACTURER. SYSTEM USED IN RESEARCH FACILITY. NO PT INJURY OR HARM WAS REPORTED AS A RESULT OF THE NOTED MALFUNCTION.
Description of Event or Problem · 1
THE GE OEC 9600 FLUOROSCOPY SYSTEM WOULD NOT ACTIVATE THE CINE FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | 9600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |