BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGUIDE SYSTEM

    MDR report key: 6633208 · Received June 12, 2017

    Report

    Report Number
    9710332-2017-00002
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Report Date
    June 12, 2017
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Product Code
    IYE
    UDI-DI
    04056719001742
    PMA / PMN Number
    K143485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER DISCOVERED DURING AN IN-HOUSE INVESTIGATION THAT IF THE PEC DATA DIALOG AFTER A VERIFICATION SCAN IS CANCELLED, A RE-SEND OF PEC DATA WILL LEAD TO INCORRECT POSITIONING BECAUSE THE 2ND PEC VALUES SUPERSEDE THE 1ST PEC VALUES INSTEAD OF BEING ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414652 IGUIDE SYSTEM ACCELERATOR, LINEAR, MEDICAL IYE MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH P10603-109 AND P10603-110 04056719001742

    Patients

    Seq Age Sex Outcome Treatment
    1