FDA Adverse Event
Malfunction
Summary report: N
2600
MDR report key: 1040808
·
Received May 9, 2008
Report
- Report Number
- 1720753-2008-21391
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 25, 2008
- Report Date
- May 8, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED A TILT MOTION ERROR DURING A CASE. SYSTEM WAS REBOOTED, CLEARING THE TILT MOTION ERROR, BUT HAD A MOTOR DISABLE ERROR AND LOSS OF LATERAL TABLE MOTION ALSO APPEARED. CUSTOMER WAS ABLE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |