BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM SMART OCCLUDER

    MDR report key: 21264511 · Received January 29, 2025

    Report

    Report Number
    3006073153-2025-00016
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 10, 2024
    Report Date
    January 29, 2025
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTQ
    UDI-DI
    05060434423436
    PMA / PMN Number
    K190282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT LOGS REVIEWED BUT COULD NOT CONFIRM THE REPORTED FAULT. EVENT LOGS SUGGEST THE QSO CLOSED AS EXPECTED WHEN A BUBBLE WAS TRIGGERED. 490 2024-01-10T18:34:54.375Z INFO BUBBLE OCCL CH1, ON (3), 491 2024-01-10T18:35:03.867Z INFO BUBBLE OCCL TRIG BY CH1, VAL 3, 492 2024-01-10T18:35:03.867Z INFO BUBBLE OCCL CH1, DISABLED, 493 2024-01-10T18:35:03.867Z INFO BUBBLE OCCL CH2, DISABLED, 494 2024-01-10T18:35:03.867Z INFO FLOW REGULATION: INTERNAL OCCLUSION REQUESTED, 495 2024-01-10T18:35:03.877Z INFO FULL OCCLUSION: HIGH PROFILE: 34.3, 496 2024-01-10T18:35:06.474Z INFO FULL OCCLUSION COMPLETED. REVIEW OF DEVICE LOGS GAVE NO INDICATION OF ANY FAULTS WITH THE QSO. UNABLE TO REPRODUCE THE REPORTED FAULT WHEN ATTEMPTED IN-HOUSE. SPECTRUM WILL WORK TO IMPROVE LOGGING IN FUTURE SOFTWARE RELEASES.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT WHILE TESTING BUBBLE DETECTION, THE ARTERIAL CLAMP DIDN'T CLAMP WHEN DETECTING A BUBBLE. THIS HAPPENED 3 TIMES IN A ROW AND WORKED FINE AFTERWARDS. FROM THE VIDEO, IT SEEMS THAT THE ARTERIAL CLAMP IS RELEASED BUT THE QWS SHOW THAT IT IS IN THE OPEN POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953544 QUANTUM SMART OCCLUDER TUBE CLAMP DTQ SPECTRUM MEDICAL LTD QSOL 05060434423436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown