BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ FLEX M

    MDR report key: 19428463 · Received May 29, 2024

    Report

    Report Number
    MW5155573
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    June 13, 2023
    Report Date
    May 23, 2024
    Manufacturer
    FIRST SOURCE INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AS A NEW EMPLOYEE I REALIZED THERE WAS A PRODUCT QUALITY ISSUE EARLY ON WITH LEAKING OIL FROM THE X-RAY GENERATOR HEAD. THERE ARE NUMEROUS COMPANY DOCUMENT INSTANCES REFLECTING THE SAME LEAKING OIL ISSUE. TWO RESULTED IN SMOKING FROM THE X-RAY MACHINE. ANOTHER RESULTED IN SPARKS (AGAIN ALL DOCUMENTED). 510(K): K221081. IQ FLEX M/MD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328747 IQ FLEX M SYSTEM, X-RAY, MOBILE IZL FIRST SOURCE INC. M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown