FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3801866
·
Received February 11, 2014
Report
- Report Number
- 1720753-2014-01355
- Event Type
- Malfunction
- Date Received
- February 11, 2014
- Date of Event
- January 28, 2014
- Report Date
- February 11, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED 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 A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR MAY RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN SITUATION. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90042 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |