FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2041333
·
Received March 23, 2011
Report
- Report Number
- 1720753-2011-02674
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 28, 2011
- Report Date
- March 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE GROUNDING CONNECTOR WAS TIGHTENED AND THE ROTATIONAL POTENTIOMETER, ROTATIONAL CONTROLLER, AND POWER SUPPLY WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM HAD A MOTION SENSOR ERROR MESSAGE DURING A CASE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |