FDA Adverse Event
Malfunction
Summary report: N
ITRAK 3500L
MDR report key: 1992952
·
Received February 5, 2011
Report
- Report Number
- 1720753-2011-00979
- Event Type
- Malfunction
- Date Received
- February 5, 2011
- Date of Event
- January 18, 2011
- Report Date
- February 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER CONTACTED A GE REPRESENTATIVE BY PHONE AND THE GE REPRESENTATIVE WAS ABLE TO DIRECT THE SURGEON IN RESETTING THE SYSTEM. THE SURGEON REBOOTED THE SYSTEM AND WAS ABLE TO CONTINUE THE CASE. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY ARE UNABLE TO CALIBRATE AND THE SYSTEM LOCKS UP. NO PATIENT 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 |