FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3963132
·
Received June 19, 2014
Report
- Report Number
- 1720753-2014-05267
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- June 4, 2014
- Report Date
- June 19, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE VOLTAGE ON 5V POWER SUPPLY WAS EVALUATED AND READJUSTED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE FE REPORTED INTERMITTENT COMMUNICATION FAILED ERROR MESSAGES. THIS ERROR RESULTS IN X-RAYS BEING DISABLED. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359437 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |