BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM LEVEL SENSOR (ACCESSORY TO THE QUANTUM DIAGNOSTIC MODULE)

    MDR report key: 20512475 · Received October 23, 2024

    Report

    Report Number
    3006073153-2024-00071
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 23, 2024
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DRY
    UDI-DI
    05060434420893
    PMA / PMN Number
    K173591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON ARRIVAL AT SPECTRUM MEDICAL INC THE REPORTED FAULT WAS UNABLE TO BE CONFIRMED, BOTH THE RED AND YELLOW LEADS ON THE SENSOR WERE ABLE TO TRIGGER A PULSE AND ALL READINGS WHERE DISPLAYED. THE SENSOR VALUES APPEARED ON THE WORKSTATION AND THE ROLLER PUMP STOPPED WHEN SAFE FLOW WAS DETECTED. THE SENSOR WAS TESTED USING THE SPT TOOL THE SENSOR TO BE INVENTORY DISPOSED DUE TO THE POSSIBILITY OF LIQUID INGRESS CAUSING IT TO MALFUNCTION.

    Description of Event or Problem · 0

    DURING SETTING UP FOR THE CASE THE TEAM NOTICED THAT THE RED PROTECTED LEVEL SENSOR WAS NOT STOPPING WHEN THEY TRIED TO TRIGGER THIS MODE. THE LIGHT ALSO STAYED ON WHEN THE FLUID WENT BELOW THE APPROPRIATE LEVEL. THE LEVEL WAS ENGAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31186 QUANTUM LEVEL SENSOR (ACCESSORY TO THE QUANTUM DIAGNOSTIC MODULE) LEVEL SENSOR DRY SPECTRUM MEDICAL LTD QLV1 05060434420893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown