FDA Adverse Event
Malfunction
Summary report: N
ITRAK 3500
MDR report key: 2934576
·
Received January 10, 2013
Report
- Report Number
- 1720753-2013-00422
- Event Type
- Malfunction
- Date Received
- January 10, 2013
- Date of Event
- December 27, 2012
- Report Date
- January 10, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE SYSTEM TRACKER WAS REPLACED AND RECONFIGURED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE FIELD ENGINEER REPORTED THAT THE TRACKER WAS NOT BOOTING, AND ITS POWER SUPPLY WAS NOT RUNNING. WHEN THE TRACKER FAILS TO BOOT UP, THE SYSTEM IS RENDERED INOPERABLE. THERE IS NOT REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 15987 | ITRAK 3500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ITRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |