BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM LEVEL SENSOR

    MDR report key: 22466413 · Received July 10, 2025

    Report

    Report Number
    3006073153-2025-00158
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 11, 2025
    Report Date
    July 10, 2025
    Manufacturer
    SPECTRUM MEDICAL
    Product Code
    DRY
    UDI-DI
    05060434422002
    PMA / PMN Number
    K173591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DUE TO BE COMPLETED ON RETURN OF DEVICE TO SPECTRUM MEDICAL LTD. FOLLOW UP 1: UPON RETURN OF DEVICE TO SPECTRUM MEDICAL SENSOR SHOWS SOME SCRATCHES ON THE HOUSING. INVESTIGATION CONFIRMS THE SENSOR READS OUT OF TOLERANCE. SENSOR RETURNED TO OEM FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION DUE TO BE COMPLETED ON RETURN OF DEVICE TO SPECTRUM MEDICAL LTD.

    Description of Event or Problem · 0

    USER REPORTED A DIFFERENCE IN FLOW BETWEEN THE SAFE FLOW PROBE AND ARTERIAL FLOW PROBE NOTED TO BE 0.5 L/MIN AT 4.0L/MIN OF FLOW. THIS FLOW PROBE WAS ABLE TO BE IDENTIFIED AND SWAPPED WITH A BACK UP DURING THE CASE. THERE WAS NO HARM TO THE PATIENT INVOLVED.

    Description of Event or Problem · 0

    USER REPORTED A DIFFERENCE IN FLOW BETWEEN THE SAFE FLOW PROBE AND ARTERIAL FLOW PROBE NOTED TO BE 0.5L/MIN AT 4.0L/MIN OF FLOW. THIS FLOW PROBE WAS ABLE TO BE IDENTIFIED AND SWAPPED WITH A BACK UP DURING THE CASE. THERE WAS NO HARD TO THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729752 QUANTUM LEVEL SENSOR BLOOD GAS MONITOR DRY SPECTRUM MEDICAL 51-000078-00 05060434422002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown