BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAWAVE

    MDR report key: 23498464 · Received November 7, 2025

    Report

    Report Number
    2015691-2025-09135
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 7, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXN
    UDI-DI
    00690103218893
    PMA / PMN Number
    K230919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PRODUCT EVALUATION AS THE DEVICE WAS NOT RETURNED. WITHOUT ITS RETURN, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS NO LOT NUMBER WAS PROVIDED. 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.

    Description of Event or Problem · 0

    AS REPORTED DURING USE THE VITA WAVE CUFF PRESSURE VALUES WERE OFF BY 40MMHG FROM THE A-LINE (188/86 VWCA2; 144/93 A-LINE). THEY ALSO FAILED TO GET A WAVEFORM AFTER STAIRSTEPS DURING INDUCTION. THEY SWITCHED FINGERS AND STRUGGLED TO GET A WAVEFORM. AFTER LETTING THE PUMP REINITIALIZE A COUPLE TIMES IT THEN WORKED. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186583 VITAWAVE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN EDWARDS LIFESCIENCES DR VWCA2 00690103218893

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown