FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9900
MDR report key: 1181806
·
Received September 19, 2008
Report
- Report Number
- 1720753-2008-26058
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 26, 2008
- Report Date
- September 19, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CUSTOMER CANCELED THE SERVICE CALL. A FOLLOW UP REPORT WILL BE FILED, WHEN ADDITIONAL DETAILS BECOME AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9900 SYSTEM HAD WASHED OUT, WHITE IMAGES DURING A CASE. THE 9900 SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |