FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1944277
·
Received December 6, 2010
Report
- Report Number
- 1720753-2010-04462
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- November 15, 2010
- Report Date
- December 6, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE RTOS AND THE SOFTWARE WERE INSTALLED 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 LOCKED UP WITH A COMMUNICATION ERROR DURING A CASE. THE 9900 SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |