FDA Adverse Event
Malfunction
Summary report: N
ITRAK 3500
MDR report key: 2102758
·
Received May 23, 2011
Report
- Report Number
- 1720753-2011-07564
- Event Type
- Malfunction
- Date Received
- May 23, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED PROBLEM. THE GE REP WAS ABLE TO PERFORM CALIBRATION AND SET VERIFICATION POINTS, AND VERIFIED WITH THE CUSTOMER THAT THE SYSTEM WAS TRACKING ACCURATELY. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WOULD NOT CENTER THE CROSS HAIRS FOR TRACKING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITRAK 3500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ITRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |