BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE IQ

    MDR report key: 10376132 · Received August 6, 2020

    Report

    Report Number
    1222993-2020-00019
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 22, 2020
    Report Date
    August 6, 2020
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELITE IQ WAS UNABLE TO ACHIEVE DESIRED FLUENCES. AN INVESTIGATION WAS CONDUCTED ON 7/22 AND FOUND ENERGY EMITTED WAS LOW AND MEASUREMENT SHOWED IT WAS GREATER THAN 20% OUT OF SPECIFICATION. THERE WAS NO REPORT OF A PATIENT INJURY RELATED TO THIS EVENT. THIS INCIDENT IS REPORTABLE BECAUSE IT IS AN ACCIDENTAL RADIATION OCCURRENCE (ARO) SINCE THE DEVICE OPERATED OUT OF SPECIFICATION RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837674 ELITE IQ ELITE IQ GEX EL. EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1