BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURORA 4

    MDR report key: 19198075 · Received April 26, 2024

    Report

    Report Number
    3006437518-2024-00010
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 25, 2024
    Report Date
    April 26, 2024
    Manufacturer
    DKK DAI-ICHI SHOMEI CO., LTD.
    Product Code
    KQM
    PMA / PMN Number
    K071698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN AUA7 LIGHT IN OPERATION ROOM 5 FELL OFF THE BOM AND CRASHED ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982447 AURORA 4 CAMERA, SURGICAL AND ACCESSORIES, PRODUCT CODE: KQM, PRODUCT CODE: KQM KQM DKK DAI-ICHI SHOMEI CO., LTD. AUA7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown