FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2101794
·
Received May 10, 2011
Report
- Report Number
- 1720753-2011-07141
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 25, 2011
- Report Date
- May 10, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE RIGHT MONITOR, GENERAL PURPOSE OPERATING SYSTEM AND REAL TIME OPERATING SYSTEM PRINTED CIRCUIT BOARDS WERE REPLACED. THE POWER SUPPLY WAS REPLACED. THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S RIGHT MONITOR TOUCH SCREEN WOULD NOT WORK OUTSIDE OF A PROCEDURE. ALSO REPORTED WAS THAT THE SYSTEM WOULD NOT REBOOT. 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 |