FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3822743
·
Received February 7, 2014
Report
- Report Number
- 1720753-2014-01268
- Event Type
- Malfunction
- Date Received
- February 7, 2014
- Date of Event
- January 28, 2014
- Report Date
- February 7, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE POWER SUPPLY ON THE LEFT MONITOR FAILED. THE CUSTOMER WAS OFFERED AN LCD UPGRADE KIT HOWEVER, THEY DECIDED TO INSTALL MONITOR FROM THIRD PARTY. THE CUSTOMER DECLINED SERVICE AT THIS TIME. NO FURTHER INFO IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO VIEW FLUOROSCOPIC IMAGE BECAUSE THE LEFT MONITOR DISPLAYED A BLACK IMAGE. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80843 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |