BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA-O2

    MDR report key: 20460796 · Received October 16, 2024

    Report

    Report Number
    20460796
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 25, 2024
    Manufacturer
    TURN MEDICAL, LLC
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PRONOVA-O2 BED (SERIAL #(B)(6)) WAS STUCK IN SUPINE AT 16 DEGREES AND WOULD NOT GO TO ZERO. WE NEEDED TO SWITCH BEDS. WHEN TRYING TO GET THE PATIENT OUT OF THIS BED AND INTO THE OTHER BED, THE SIDE RAIL ON THE RIGHT ARM WOULD NOT MOVE SO WE HAD TO REARRANGE ROOM AND MOVE HIM OUT OF THE LEFT SIDE OF HIS BED INTO THE NEW BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568102 PRONOVA-O2 BED, PATIENT ROTATION, POWERED IKZ TURN MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Unknown