BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSIO® ICP MONITORING KIT, VENTRICULAR TUNNELING

    MDR report key: 19547517 · Received June 17, 2024

    Report

    Report Number
    3001587388-2024-00193
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 9, 2026
    Manufacturer
    SOPHYSA SA
    Product Code
    GWM
    UDI-DI
    03760124131482
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MACHINE SHOWED 33 MMHG WHEN THE CATHETER WAS CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582973 PRESSIO® ICP MONITORING KIT, VENTRICULAR TUNNELING ICP MONITORING CATHETER GWM SOPHYSA SA PSO-VT 03760124131482

    Patients

    Seq Age Sex Outcome Treatment
    1