FDA Adverse Event
Malfunction
Summary report: N
GE OEC 7600
MDR report key: 1202153
·
Received October 16, 2008
Report
- Report Number
- 9680959-2008-00192
- Event Type
- Malfunction
- Date Received
- October 16, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 16, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CUSTOMER CANCELLED 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 7600 SYSTEM HAD POOR IMAGE QUALITY DURING A CASE. THE 7600 SYSTEM HAD TO BE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 7600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |