BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM INTERSEGMENTAL TABLE

    MDR report key: 23318345 · Received October 16, 2025

    Report

    Report Number
    3007278668-2025-00003
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 16, 2025
    Manufacturer
    PIVOTAL HEALTH SOLUTIONS, INC.
    Product Code
    ISA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF PHOTOS PROVIDED BY CUSTOMER OF PRIOR FAILURE 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 GET HOT AND THE PATIENT FELT THE HEAT AND HAD A RED MARK ON THEIR ARM. THERE WAS NO PAIN, BURNING OR DISCOMFORT AND THE PATIENT DID NOT REQUIRE ANY FURTHER MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254108 QUANTUM INTERSEGMENTAL TABLE QUANTUM ISA PIVOTAL HEALTH SOLUTIONS, INC. Q400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown