FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2833601
·
Received October 29, 2012
Report
- Report Number
- 1720753-2012-08790
- Event Type
- Malfunction
- Date Received
- October 29, 2012
- Date of Event
- October 18, 2012
- Report Date
- October 29, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE GENERAL PURPOSE OPERATING SYSTEM WAS REPLACED AND THE SOFTWARE WAS RELOADED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD INTERMITTENTLY DISPLAY A COMMUNICATION FAILURE ERROR MESSAGE AND LOCK-UP. THERE IS NO REPORT OF PT INJURY.
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 |