BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM WORKSTATION 12" ELITE

    MDR report key: 21979600 · Received May 7, 2025

    Report

    Report Number
    3006073153-2025-00114
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 4, 2025
    Report Date
    May 7, 2025
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DRY
    UDI-DI
    05060434422309
    PMA / PMN Number
    K202557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FOUND THAT USER UNINTENTIONALLY SHUT DOWN THE SYSTEM DURING THE PROCEDURE. SPECTRUM MEDICAL LTD HAS CONSIDERED THIS POTENTIAL USE ERROR IN IMPROVEMENTS TO THE SOFTWARE, WHICH PREVENTS SHUTDOWN COMMANDS WHILE THE PUMP IS ACTIVE.

    Description of Event or Problem · 0

    USER REPORTED SYSTEM SCREENS WENT BLANK AND PUMP STOPPED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144421 QUANTUM WORKSTATION 12" ELITE MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS DRY SPECTRUM MEDICAL LTD QWS12E 05060434422309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown