BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK 3500

    MDR report key: 2153486 · Received June 21, 2011

    Report

    Report Number
    1720753-2011-08392
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. TECHNICAL SUPPORT WAS PROVIDED TO THE CUSTOMER TO PLACE THE INSTRUMENT TO THE DIMPLE OF THE HOCKEY PUCK TRANSMITTER FOLLOWING WHICH THE PHYSICIAN WAS ABLE TO SUCCESSFULLY CALIBRATE THE MICRO-DEBRIDER. THE SYSTEM WAS WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PHYSICIAN WAS NOT ABLE TO CALIBRATE THE MICRO-DEBRIDER AND THE SYSTEM DISPLAYED AN ERROR MESSAGE REQUESTING THE TOP OF THE INSTRUMENT BE PLACED IN THE SURGICAL FIELD. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTATRAK 3500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) INSTATRAK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1