FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3792020
·
Received January 14, 2014
Report
- Report Number
- 1720753-2014-00452
- Event Type
- Malfunction
- Date Received
- January 14, 2014
- Date of Event
- December 31, 2013
- Report Date
- January 14, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INSTIGATION. THE LEFT MONITOR WAS REPLACED 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 FE REPORTED THAT THE LEFT MONITOR WAS FLICKERING AND UNABLE TO SEE THE IMAGE. THIS RESULTED IN A TOTAL 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 |
|---|---|---|---|---|---|---|---|
| 36077 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |