FDA Adverse Event
Malfunction
Summary report: N
9600EMI
MDR report key: 1150595
·
Received September 9, 2008
Report
- Report Number
- 1720753-2008-24634
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 13, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE REP FOUND DISTORTED IMAGES WHEN COMPLETING A CINE RUN. HE CHECKED VOLTAGES, ALL OK. HE RESEATED ALTA, AT COMMUNICATION AND IMAGE PROCESSOR PCB. USED ESD MAT ON SERVICE CALL WITH ANTI STATIC PRECAUTIONS. THE REP REPLACED AND INSTALLED SCUZZI CONTROLLER PCB AND SCUZZI HARD DRIVE. HE VERIFIED SYSTEM RECORDS CINE RUNS PROPERLY. THE SYSTEM IS OPERATING BY FLUOROING IN LOW AND HIGH TECHNIQUE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A DISTORTED IMAGE WHEN DOING A CINE RUN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600EMI | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |