FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3860510
·
Received April 15, 2014
Report
- Report Number
- 1720753-2014-03270
- Event Type
- Malfunction
- Date Received
- April 15, 2014
- Date of Event
- March 23, 2014
- Report Date
- April 15, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE F4 FUSE ON THE POWER RELAY PCB WAS EVALUATED AND IDENTIFIED AS REQUIRING REPLACEMENT. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM EXHIBITED 'PRE-CHARGE ERRORS' UPON SYSTEM START UP. THIS ERROR IS LIKELY TO PREVENT THE SYSTEM FROM BOOTING TO A USABLE STATE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230620 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |