BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON AURORA FOUR

    MDR report key: 12566938 · Received October 4, 2021

    Report

    Report Number
    3006437518-2021-00003
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    August 12, 2021
    Report Date
    October 4, 2021
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD.
    Product Code
    FTA
    PMA / PMN Number
    K071698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021, DKK WAS INFORMED THAT AN AUA5LH LIGHT WAS EXPERIENCING RUSTING AND CORROSION AROUND THE BOM AND RADIAL ARM, AND THAT THE PAINT WAS FLAKING OFF AND THE BEARINGS WERE SEIZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464404 SKYTRON AURORA FOUR LIGHT, SURGICAL, ACCESSORIES FTA DAI-ICHI SHOMEI CO., LTD. AUA5LH

    Patients

    Seq Age Sex Outcome Treatment
    1