BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM

    MDR report key: 24188086 · Received January 27, 2026

    Report

    Report Number
    3006073153-2026-00010
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 15, 2026
    Report Date
    May 21, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTX
    UDI-DI
    05060434422064
    PMA / PMN Number
    K202733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL ONGOING. HOWEVER, PRELIMINARY FINDINGS SHOW THAT JUST BEFORE GOING ON BYPASS SOMEONE DISABLED, ENABLED AND IN THE END DISABLED THE SPECTRUM OXY FUNCTIONALLITY WHICH RESULTED IN ONLY VENTILATION ON THE 40% GREEN CHAMBER OF THE SPECTRUM OXY. WHICH RESULTED IN THE MENTIONED LOW PO2, BUT THE FAULTY CALCULATION OF PO2 ON THE QWS. A FURTHER FOLLOW UP INVESTIGATION WILL DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 0

    CUSTOMER DID A BYPASS WITH FIO2 OF 60% AND NORMAL SWEEP. NO PHYSIOLOGIC ACTIVATED OR ANY AUTOREGULATION. PERFUSIONIST THOUGHT THAT BLOOD WAS DARK. BUT PO2 ON QWS SHOWED 500 MMHG, SO VERY HIGH. BLOODGAS SHOWED A INITIAL PO2 OF 90 MMHG SO A VERY BIG DISCREPANCY. THEN RAISED THE FIO2, BUT THAT DIDNT SOLVE MUCH. SO DECIDED TO SWITCH TO EXTERNAL BACK UP GASBLENDER WITH Y CONNECTION (DUE TO DUAL CHAMBER). UPON QUERY ASKED SPECTRUM OXY WAS NOT ACTIVATED. ENGINEER ACTIVATED IT IN SETTINGS. CUSTOMER DECIDED TO GO BACK TO VENTILATION WITH QVM AND THEY FINISHED THE CASE WITHOUT DAMAGE TO THE PATIENT.

    Description of Event or Problem · 0

    CUSTOMER DID A BYPASS WITH FIO2 OF 60% AND NORMAL SWEEP. NO PHYSIOLOGIC ACTIVATED OR ANY AUTOREGULATION. PERFUSIONIST THOUGHT THAT BLOOD WAS DARK. BUT PO2 ON QWS SHOWED 500 MMHG, SO VERY HIGH. BLOODGAS SHOWED SHOWED A INITIAL PO2 OF 90 MMHG SO A VERY BIG DISCREPANCY. THEN RAISED THE FIO2, BUT THAT DIDNT SOLVE MUCH. SO DECIDED TO SWITCH TO EXTERNAL BACK UP GASBLENDER WITH Y CONNECTION (DUE TO DUAL CHAMBER). UPON QUERY ASKED SPECTRUM OXY WAS NOT ACTIVATED. ENGINEER ACTIVATED IT IN SETTINGS. CUSTOMER DECIDED TO GO BACK TO VENTILATION WITH QVM AND THEY FINISHED THE CASE WITHOUT DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304 QUANTUM QUANTUM VENTILATION MODULE DTX SPECTRUM MEDICAL LTD QVM2-N-HM 05060434422064

    Patients

    Seq Age Sex Outcome Treatment
    1