FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 3823489
·
Received February 19, 2014
Report
- Report Number
- 1720753-2014-01662
- Event Type
- Malfunction
- Date Received
- February 19, 2014
- Date of Event
- February 3, 2014
- Report Date
- February 19, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE MOV ON THE POWER SIGNAL INTERFACE PCB WAS EVALUATED AND IDENTIFIED AS REQUIRING REPLACEMENT. THE REPORTED PROBLEM WAS TO BE RESOLVED BY THE CUSTOMER. NO ADD'L SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104692 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |