BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM INTERSEGMENTAL TABLE

    MDR report key: 23095560 · Received September 19, 2025

    Report

    Report Number
    3007278668-2025-00001
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 16, 2025
    Manufacturer
    PIVOTAL HEALTH SOLUTIONS, INC.
    Product Code
    ISA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS BEING RETURNED TO MANUFACTURER FOR EVALUATION. EVALUATION OF INITIAL INFORMATION DETERMINED IT WAS LIKELY THERE WAS MATERIAL BREAKDOWN OF HEAT COMPONENT CAUSED BY ACCELERATED WEAR AND REPEATED PINPOINT PRESSURE FROM PATIENT LOADING/UNLOADING RESULTING IN AN ELECTRICAL SHORT WITHIN THE INTERNAL COILS OF THE HEATING ELEMENT.

    Description of Event or Problem · 0

    A HEAT FUNCTION ON A QUANTUM TABLE MANUFACTURED IN 2010 MALFUNCTIONED AND OVERHEATED CAUSING THE VINYL TO MELT AND SMOLDER LEAVING A HOLE IN THE VINYL CUSHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397868 QUANTUM INTERSEGMENTAL TABLE QUANTUM ISA PIVOTAL HEALTH SOLUTIONS, INC. Q400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown