FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 950522
·
Received November 20, 2007
Report
- Report Number
- 1720753-2007-07817
- Event Type
- Malfunction
- Date Received
- November 20, 2007
- Date of Event
- October 26, 2007
- Report Date
- November 19, 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 REPLACED AND ALIGNED THE LEFT (LIVE) MONITOR. JAZ DRIVE REPLACED, ALTHOUGH, THE TRANSFER ISSUE COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED, FOUND TO BE FUNCTIONING AS INTENDED AND RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PATIENT INFORMATION WITH RESPECT TO THIS ISSUE. NO PATIENT INJURY OR HARM WAS REPORTED AS A RESULT OF THE NOTED MALFUNCTION.
Description of Event or Problem · 1
THE GE OEC 9800 FLUOROSCOPY SYSTEM HAD THE LEFT (LIVE) MONITOR GO DIM, AND NOT RECOVER UNTIL THE SYSTEM WAS RE-BOOTED. ALSO REPORTED IMAGE TRANSFER ISSUE TO DISK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |