FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3823006
·
Received February 5, 2014
Report
- Report Number
- 1720753-2014-01182
- Event Type
- Malfunction
- Date Received
- February 5, 2014
- Date of Event
- January 17, 2014
- Report Date
- February 5, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE CAMERA WAS EVALUATED AND REPLACED. THE DOSE WAS RECALIBRATED AND BEAM ALIGNMENT WAS PERFORMED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE LEFT LIVE MONITOR FAILED TO DISPLAY FLUOROSCOPIC IMAGE. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75881 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |