BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS CSF EXTERNAL DRAINAGE SYSTEM

    MDR report key: 19593205 · Received June 24, 2024

    Report

    Report Number
    19593205
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 19, 2024
    Report Date
    May 30, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BREAK IN CLAMP THAT ATTACHES TO IV POLE. BREAK IN CLAMP THAT ATTACHES TO IV POLE ¿ NATUS CSF (CEREBROSPINAL FLUID) EXTERNAL DRAINAGE SYSTEM (NATUS MEDICAL INCORPORATED). RN (REGISTERED NURSE) TOOK THE PRESSURE SCALE/CHAMBER OF THE EVD OFF THE POLE TO RE-LEVEL. RN WENT TO TIGHTEN THE BLUE SCREW OF THE EVD TO THE POLE AND THE ¿WHITE¿ PIECE BELOW BROKE OFF CAUSING THE ENTIRE EVD SYSTEM TO BE TILTED. MANUFACTURER RESPONSE FOR NATUS CSF EXTERNAL DRAINAGE SYSTEM, (BRAND NOT PROVIDED) (PER SITE REPORTER). WORKING WITH US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194758 NATUS CSF EXTERNAL DRAINAGE SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG NATUS MEDICAL INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown