FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2193143
·
Received July 22, 2011
Report
- Report Number
- 1720753-2011-20298
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SRAM CARD WAS REPLACED. THE BOOST DOSE RATE WAS SET. THE SYS 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 SYS DISPLAYED A CHECK SUM ERROR MESSAGE AND THE BOOT UP PROCESS WAS TERMINATED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |