BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE PRESSURE MONITORING SET

    MDR report key: 20521952 · Received October 24, 2024

    Report

    Report Number
    20521952
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    August 13, 2024
    Report Date
    October 16, 2024
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CHANGING OUT THE ALINE TUBING, PLUGGED IN THE NEW TRANSDUCER AND THERE WAS NO WAVEFORM AND WOULD NOT ZERO. MY A-LINE STILL DREW BACK BLOOD AND FLUSH EASILY. OPTIMIZED THE SCALE, DISCONCERTED FROM MONITOR AND RECONNECTED. A SECOND NURSE ALSO ATTEMPTED AT TROUBLESHOOTING THE PROBLEM AS WELL. I WENT AND GOT SECOND TRANSDUCER AND IT WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790639 TRUWAVE PRESSURE MONITORING SET TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES LLC PX284R 65503716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose