FDA Adverse Event
Malfunction
Summary report: N
9800EMI
MDR report key: 1141103
·
Received September 3, 2008
Report
- Report Number
- 1720753-2008-24416
- Event Type
- Malfunction
- Date Received
- September 3, 2008
- Date of Event
- July 28, 2008
- Report Date
- August 7, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ERROR CODE WAS DISPLAYED. CUSTOMER CANCELLED CALL; THE SYSTEM WAS FULLY FUNCTIONAL, THIS CASE IS CLOSED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN ERROR DISPLAYED WHEN RETRIEVING IMAGES FROM HARD DRIVE, HOWEVER, THE SYSTEM WAS FULLY FUNCTIONAL AFTER REBOOTING. THE PROBLEM OCCURRED AFTER COMPLETING THE PROCEDURE. NO PATIENT INJURIES WERE RECORDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800EMI | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |