BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM WORKSTATION

    MDR report key: 25123020 · Received May 8, 2026

    Report

    Report Number
    3006073153-2026-00128
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 8, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD.
    Product Code
    DRY
    UDI-DI
    05060434422293
    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

    LOGS REVIEW SHOWS THERE WAS A PC COMMS LOSS DURING THE REPORTED EVENT. DURING THE DEVICE COMMS LOSS, GAS AND BLOOD FLOW WERE NOT INTERRUPTED. THE INTERNAL RESYNC OF COMMS AUTOMATICALLY RE-ESTABLISHED ALL COMMUNICATIONS, BY DESIGN. UPON RECEIPT DEVICE PRESENTS NO OBVIOUS SIGNS OF DAMAGE. UNABLE TO REPLICATE REPORTED ISSUE REBOOTING DEVICE MULTIPLE TIMES TO FORCE COMMUNICATION RESTART. ROOT CAUSE DETERMINED TO BE SOFTWARE FAULT. DEVICE COMMS ARE IMPROVED IN SOFTWARE 6.8+. CONFIRMED OS IS UPDATED TO LATEST VERSION. COMPLETED PREVENTATIVE MAINTENANCE SUCCESSFULLY. AS THIS IS THE SECOND REPORT FOR THIS ERROR CODE ON THIS SERIAL NUMBER, DEVICE IS BEING PERMANENTLY REPLACED WITH DEVICE ON SITE. NO PATIENT HARM OR DELAYS TO THE SURGERY.

    Description of Event or Problem · 0

    QWS HAD UNEXPECTED SHUT-DOWN MID-CASE. POWER BUTTON DID NOT APPEAR TO HAVE BEEN PRESSED FOR 10 SECONDS BY USER OR PUSHING AGAINST OTHER EQUIPMENT. QWS BOOTED BACK UP INDEPENDENTLY WITH SPECTRUM LOGO ROTATED 45 DEGREES AND "SYSTEM ERROR" MESSAGE DISPLAYED ON THE SCREEN. QWS SHUT ITSELF OFF AGAIN AND BOOTED BACK UP PROPERLY IMMEDIATELY AFTER. USER WAS STILL ON BYPASS AND DID NOT ATTEMPT A HARD REBOOT OF THE QWS OR A SWAP TO A NEW QWS. ALL TIMERS, RECORD, ETC. WERE LOST UPON QWS START UP BUT NO OTHER EFFECTS TO OPERATIONS OF THE REST OF THE HLM. AFTER THE CASE LOGS WERE PULLED AND NO REPORTS OF FAILURE SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54345 QUANTUM WORKSTATION EXTRACORPOREAL BLOOD GAS/PH MONITOR DRY SPECTRUM MEDICAL LTD. QWS15S 05060434422293

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown