BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE IQ

    MDR report key: 19840921 · Received July 26, 2024

    Report

    Report Number
    1222993-2024-00040
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Report Date
    July 26, 2024
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    UDI-DI
    08057017760450
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE ELITE IQ FOOT PEDAL WAS INTERMITTENT AND DOUBLE PULSES. NO PATIENT INJURIES WERE REPORTED. FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE SITE AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND TO BE OPERATING AS INTENDED WITHIN SPECIFICATION. TO RESOLVE THE CUSTOMER'S REPORTED ISSUE, FSE REPLACED THE FOOT PEDAL. DUE TO THE SITE REPORTING UNINTENDED DISCHARGES OF LASER ENERGY, THIS EVENT IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) AND THEREFORE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735102 ELITE IQ ELITE IQ GEX EL. EN. ELECTRONIC ENGINEERING SPA 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown