BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM INTERSEGMENTAL TABLE

    MDR report key: 24611723 · Received March 16, 2026

    Report

    Report Number
    3007278668-2026-00004
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Report Date
    March 16, 2026
    Manufacturer
    PIVOTAL HEALTH SOLUTIONS
    Product Code
    ISA
    Removal / Correction Number
    97861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HEATING FUNCTION WAS DISABLED.

    Description of Event or Problem · 0

    THE PRODUCT'S HEAT FUNCTION HAD MALFUNCTIONED, THERE WAS SMOKE. NO PATIENT WAS ON THE TABLE. IT OCCURRED YEARS AGO, DATE UNKNOWN. HOWEVER OTHER REPORTS OF A SIMILAR INCIDENT INDICATED POTENTIAL SAFETY RISK SO REPORT IS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672447 QUANTUM INTERSEGMENTAL TABLE QUANTUM ISA PIVOTAL HEALTH SOLUTIONS QS400PH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown