BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEEGO

    MDR report key: 14676347 · Received June 10, 2022

    Report

    Report Number
    MW5110261
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    June 8, 2022
    Report Date
    June 8, 2022
    Manufacturer
    SIEMENS AG, HEALTHCARE SECTOR
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ARTIS ZEEGO UNIT WITH ONLY THE UP AND DOWN DETECTOR FEATURE WORKING. REMOTE UNIT POWER SCREEN NOTED "NO 2818, ACKN. CABINET FAN FAILURE". FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687689 ARTIS ZEEGO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS AG, HEALTHCARE SECTOR ARTIS ZEEGO

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male