BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE

    MDR report key: 21994808 · Received May 9, 2025

    Report

    Report Number
    2015691-2025-03693
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 23, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXO
    UDI-DI
    07460691957060
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION, HOWEVER, IT HAS NOT ARRIVED. ONCE IT ARRIVES AND THE EVALUATION COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE FINDINGS. THE DEVICE HISTORY RECORD REVIEW IS PENDING. ONCE THE RESULTS ARE AVAILABLE THEY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. ADDITIONAL 510K NUMBER, K171996.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. 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 IS SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AN ENGINEERING EVALUATION WAS COMPLETED 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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 PART OF THE MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A TRUWAVE PRESSURE MONITORING SET THAT THE TRANSDUCER CONNECTOR WAS NOTED TO BE LOOSE AND STRIPPED WITH AN UNSEALED OR LOOSE CONNECTION TO THE LUMBAR DRAIN. PER THE CUSTOMER, THIS CREATED INACCURATE VALUES. THE INFORMATION WAS PROVIDED THROUGH A VOLUNTARY MEDWATCH. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847796 TRUWAVE PRESSURE MONITORING SET DXO EDWARDS LIFESCIENCES PX600 65170575 07460691957060

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown