FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3792253
·
Received January 13, 2014
Report
- Report Number
- 1720753-2014-00403
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- January 2, 2014
- Report Date
- January 13, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DISK DRIVE WAS EVALUATED AND REPLACED. THE SYSTEM SOFTWARE AND CALIBRATIONS WERE ALSO RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED HARD DRIVE CORRUPTION ERRORS AND FAILED TO BOOT TO A USABLE STATE. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33373 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |