BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE

    MDR report key: 24941790 · Received April 21, 2026

    Report

    Report Number
    2015691-2026-14557
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 21, 2026
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    UDI-DI
    07460691957077
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PREMARKET SUBMISSION: K171996. DEVICE WILL NOT BE RETURNED DUE TO PATIENT ISOLATION. WITHOUT THE RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. LOT NUMBER IS EITHER 66782059, 66844009, OR 66660623. WITH THE PROVIDED LOT NUMBERS, A DEVICE HISTORY RECORD INVESTIGATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE DEVICE HISTORY RECORD INVESTIGATION IS COMPLETE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. NO ROOT CAUSE COULD BE IDENTIFIED SINCE NO PRODUCT SAMPLE NOR OBJECTIVE EVIDENCE WAS PROVIDED FOR INVESTIGATION. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH A VISUAL INSPECTION BY MANUFACTURING, VISUAL SAMPLING BY CONTINUOUS PROCESS MONITORING, AND VISUAL SAMPLING BY QUALITY ASSURRANCE. WITH THE PROVIDED LOT NUMBERS, THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, A TRUWAVE TRANSDUCER DISCONNECTED FROM A MEDTRONIC DUET EVD SYSTEM. STAFF TRIED MULTIPLE TIMES TO SECURE THE TRANSDUCER. THERE WAS NO MEDICATION OR BLOOD LEAKAGE AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51462 TRUWAVE TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PX600I 07460691957077

    Patients

    Seq Age Sex Outcome Treatment
    1