BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSAR UNIVERSAL XL

    MDR report key: 23921696 · Received December 30, 2025

    Report

    Report Number
    23921696
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    November 8, 2025
    Report Date
    December 8, 2025
    Manufacturer
    SEMLER TECHNOLOGIES, INC.
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: PULLING RIGHT FEMORAL ARTERIAL SHEATH. USING A C-CLAMP TO REMOVE SHEATH. ACT [ACTIVATED CLOTTING TIME] 148, NO COMPLICATIONS WITH SHEATH. PLACED C-CLAMP ON GROIN AND STOPPED ON END OF SHEATH BROKE OFF CAUSING CLAMP TO FAIL HOLDING PRESSURE. MANUAL PRESSURE WAS HELD. DISTAL DORSALIS PEDIS PULSES MULTIPHASIC BY DOPPLER. GROIN REMAINED SOFT WITHOUT SIGNS OF HEMATOMA OR BLEEDING. BROKEN EQUIPMENT CONTRIBUTED TO EVENT. WE WILL NEED A NEW C-CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768822 COMPRESSAR UNIVERSAL XL CLAMP, VASCULAR DXC SEMLER TECHNOLOGIES, INC. 6000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male