BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM WORKSTATION

    MDR report key: 24143302 · Received January 22, 2026

    Report

    Report Number
    3006073153-2026-00005
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 11, 2025
    Report Date
    January 16, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD.
    Product Code
    DRY
    UDI-DI
    05060434420008
    PMA / PMN Number
    K163657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SERVICE HISTORY SHOWS NO PRIOR ISSUES WITH SAT/HB LOG REVIEW REVEALS NO ISSUES/ERRORS. DEVICE TO BE INVESTIGATED ON RETURN TO MANUFACTURER.

    Description of Event or Problem · 0

    ON BYPASS INITIATION, NOT GETTING VALUES REPORTED FOR THE SAT/CRIT SENSOR. THE PROBLEM PERSISTED AFTER THE CABLE WAS REPLACED WITH THE NEW BONDED STOCK SAT/CRIT CABLE. THEY WERE ABLE TO COMPLETE CASES WITH INTERMITTENT AND ABSENT PAO2 AND HGB PRODUCING "!!!" -OR- "---." DURING TROUBLESHOOTING IT WAS IDENTIFIED THAT THE CONNECTION ON THE QWS SEEMED TO IMPROVE OR TEMPORARILY RESTORE THE SIGNAL WHEN IT WAS MANIPULATED. SUSPECTING THERE TO BE AN ISSUE WITH THE QWS DATA PORT. HAPPENED FOR CASES ON BOTH ON (B)(6). ON (B)(6): 1045-1450, ON (B)(6): 1030-1130.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208589 QUANTUM WORKSTATION EXTRACORPOREAL BLOOD GAS/PH MONITOR DRY SPECTRUM MEDICAL LTD. QVM 05060434420008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other