BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORANTECH

    MDR report key: 20586982 · Received November 1, 2024

    Report

    Report Number
    20586982
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    August 3, 2024
    Report Date
    August 21, 2024
    Manufacturer
    ORANTECH INC.
    Product Code
    IKD
    UDI-DI
    06941691962656
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE SETTING UP THE INTENSIVE CARE UNIT (ICU) ROOM, NOTED THAT THE PLASTIC COVER THAT PROTECTS THE OXYGEN SATURATION (SPO2) ADAPTER END TO THE PATIENT WAS MISSING, PRESUMED BROKEN AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189370 ORANTECH CABLE, ELECTRODE IKD ORANTECH INC. SA-015RB-30 1240418010 06941691962656

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown