BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PUMP CONSOLE

    MDR report key: 20093699 · Received August 29, 2024

    Report

    Report Number
    3006073153-2024-00043
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 20, 2024
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTQ
    PMA / PMN Number
    K173834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TEAM REPORTED THAT DURING SETUP THEIR QWS ON THE HLM SHUT DOWN ON ITS OWN. ALL OTHER MODULES STAYED ON. USER REBOOTED THE QWS AND AFTER ABOUT 30SECONDS - 1MIN THE QWS TURNED OFF AGAIN ON ITS OWN BUT THIS TIME IT TURNED ALL OTHER MODULES OFF TOO. TEAM IS UNABLE TO REPRODUCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269405 QUANTUM PUMP CONSOLE HEART-LUNG MACHINE DTQ SPECTRUM MEDICAL LTD QWS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown