FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2971523
·
Received February 4, 2013
Report
- Report Number
- 1720753-2013-01404
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- January 24, 2013
- Report Date
- February 4, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR INTERFACE BOARD WAS REPLACED AND THE CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED COMMUNICATION AND CONTROL PANEL ERROR MESSAGES. THESE ERRORS WILL LIKELY RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURRED. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47346 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |