FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1070109
·
Received July 9, 2008
Report
- Report Number
- 1720753-2008-20426
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- March 18, 2008
- Report Date
- April 4, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE SERVICE CALL WAS CANCELLED BY THE CUSTOMER. A FOLLOW UP REPORT WILL BE FILED WHEN ADD'L DETAILS BECOME AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9800 SYSTEM INTERMITTENTLY LOCKED UP DURING A CASE. THE 9800 SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |