BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM VENTILATION MODULE

    MDR report key: 19678819 · Received July 5, 2024

    Report

    Report Number
    3006073153-2024-00010
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 5, 2024
    Manufacturer
    SPECTRUM MEDICAL LIMITED
    Product Code
    DTX
    UDI-DI
    05060434422071
    PMA / PMN Number
    K202733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LOGS WERE REVIEWED TO CONFIRM THE VAVD WAS UNABLE TO MAINTAIN ITS SETPOINT. THE FAULTY UNIT WAS RETURNED TO SPECTRUM MEDICAL WHERE THE REPORTED FAULT WAS CONFIRMED AGAIN; THE VAVD WAS UNABLE TO MAINTAIN SETPOINT. THE VACUUM REGULATOR WAS REPLACED WITHIN THE UNIT AND NOW MAINTAINS VAVD AS EXPECTED. THE FAULTY VACUUM REGULATOR HAS BEEN RETURNED TO SPECTRUM MEDICAL LTD FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    DURING THE SET UP FOR A CASE, THE PERFUSIONIST TESTED THE VACUUM AND FOUND IT TO BE NOT BEHAVING AS EXPECTED. WHEN THE VACUUM WAS SET TO -20 THE READING WAS BOUNCING AROUND ANYWHERE FROM 0 TO -12. THE PERFUSIONIST CLAMPED RIGHT UNDER THE INLET OF THE VACUUM AFTER SETTING THE VACUUM TO -20 BUT THE READING WAS STILL READING ALL OVER THE PLACE. THE PERFUSIONIST INCREASEED THE VACCUM TO -100 AND BROUGHT IT BACK DOWN BUT THE READING WAS STILL STRAYING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478644 QUANTUM VENTILATION MODULE GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SPECTRUM MEDICAL LIMITED QVM2-D-HM 05060434422071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown