FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2934602
·
Received January 10, 2013
Report
- Report Number
- 1720753-2013-00459
- Event Type
- Malfunction
- Date Received
- January 10, 2013
- Date of Event
- December 19, 2012
- Report Date
- January 10, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. 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 CUSTOMER REPORTED THAT THE LEFT MONITOR WENT BLACK. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE 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 |
|---|---|---|---|---|---|---|---|
| 16224 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |