BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HB-SO2 TWIN 2.0M SENSOR 9/16"(3/8 X 3/32)

    MDR report key: 23334652 · Received October 20, 2025

    Report

    Report Number
    3006073135-2025-00261
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    October 9, 2025
    Report Date
    October 20, 2025
    Manufacturer
    SPECTRUM MEDICAL LTD.
    Product Code
    DRY
    UDI-DI
    05060434420602
    PMA / PMN Number
    K202557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE BEING RETURNED, TO BE INVESTIGATED ON RETURN.

    Description of Event or Problem · 0

    A SAT/HGB PROBE WAS REPORTED AS DISPLAYING!!! FOR SAO2 AND HGB READINGS. THE CLINICAL TEAM PERFORMED A HARD REBOOT OF THE PROBE AND TRIED IT ON A SUBSEQUENT CASE WITH THE SAME RESULT. UNFORTUNATELY, THIS IS BEING REPORTED A WEEK AFTER THE FACT AND THE CLINICAL TEAM IS NOT SURE WHICH QWS THIS OCCURRED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323105 HB-SO2 TWIN 2.0M SENSOR 9/16"(3/8 X 3/32) EXTRACORPOREAL BLOOD GAS/PH DRY SPECTRUM MEDICAL LTD. HBS4-200 05060434420602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown