FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3963085
·
Received June 23, 2014
Report
- Report Number
- 1720753-2014-05322
- Event Type
- Malfunction
- Date Received
- June 23, 2014
- Date of Event
- June 5, 2014
- Report Date
- June 20, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BATTERY AND SNUBBER BOARD WERE REPLACED ND THE FILAMENT WAS CALIBRATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED GETTING A REBOOT ERROR AND THE SYSTEM'S IMAGES WERE BLACK. THIS COULD CAUSE THE SYSTEM TO BECOME UNUSABLE DUE TO THE LOSS OF LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364619 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |