FDA Adverse Event
Malfunction
Summary report: N
ITRAK 3500L
MDR report key: 1992932
·
Received February 5, 2011
Report
- Report Number
- 1720753-2011-00981
- Event Type
- Malfunction
- Date Received
- February 5, 2011
- Date of Event
- January 20, 2011
- Report Date
- February 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER CONTACTED A GE REP AND THE GE REP SUGGESTED REBOOTING THE SYSTEM VIA KEYBOARD. THE SYSTEM RECOVERED FULLY ON REBOOT, THEN LOADED PT DATA TO VISUALIZATION MODE FOLLOWED BY CALIBRATE MODE, THEN VERIFY MODE TO ENABLE TRACKING. THE DOCTOR CONFIRMED TRACKING TO BE AS EXPECTED ON TESTS TO HEADSET AND ANATOMY. CASE WAS ABLE TO CONTINUE WITH NAV SYSTEM SUPPORT. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM LOCKED UP IN VISUALIZATION MODE AT THE BEGINNING OF A CASE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITRAK 3500L | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ITRAK 3500L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |