BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM

    MDR report key: 24256302 · Received February 4, 2026

    Report

    Report Number
    3006073153-2026-00016
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 23, 2026
    Report Date
    May 26, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTX
    UDI-DI
    05060434422064
    PMA / PMN Number
    K202733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY RESULTS SHOWED THAT WITH NO LEVEL SENSOR CONNECTED, THE SYSTEM DISPLAYS LEVEL 2 ON QWS AND SPT. WHEN THE LEVEL SENSOR IS CONNECTED, THE SYSTEM DISPLAYS LEVEL 0, AND NO LIGHT IS EMITTED FROM THE SENSOR. THIS INDICATES A POTENTIAL FAULT WITH THE PCBA - FPL. ROOT CAUSE AND INVESTIGATION SUMMARY WITH FOLLOW IN FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS BEING RETURNED AND AN INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE QUANTUM VENTILATION MODULE UNITS WERE FUNCTIONING AS EXPECTED; HOWEVER, WHEN THE LEVEL SENSOR WAS CONNECTED TO THE QVM, IT FAILED TO OPERATE PROPERLY. WHEN THE PROTECTED/SAFE LEVEL SAFETY WAS ENGAGED, THE LED ON THE LEVEL SENSOR DID NOT ILLUMINATE WHEN FLUID WAS PRESENT.

    Description of Event or Problem · 0

    THE QUANTUM VENTILATION MODULE UNITS WERE FUNCTIONING AS EXPECTED; HOWEVER, WHEN THE LEVEL SENSOR WAS CONNECTED TO THE QVM, IT FAILED TO OPERATE PROPERLY. WHEN THE PROTECTED/SAFE LEVEL SAFETY WAS ENGAGED, THE LED ON THE LEVEL SENSOR DID NOT ILLUMINATE WHEN FLUID WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129608 QUANTUM QUANTUM VENTILATION MODULE DTX SPECTRUM MEDICAL LTD QVM2-N-HM 05060434422064

    Patients

    Seq Age Sex Outcome Treatment
    1