BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAWAVE

    MDR report key: 23659709 · Received November 26, 2025

    Report

    Report Number
    2015691-2025-09611
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 7, 2025
    Report Date
    February 19, 2026
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DQK
    UDI-DI
    00690103219609
    PMA / PMN Number
    K243781
    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

    REPORT WITH FDA REPORT ID NUMBER 2015691-2025-09614 WAS SUBMITTED FOR THE PC1Q THAT WAS USED DURING THE CASE. A DEVICE HISTORY RECORD CANNOT BE COMPLETED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS FOUND TO BE A DUPLICATE OF AN EXISTING REPORT, 2015691-2025-09137.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: DQE, QAQ, MUD, DXN, DSB, FLL, QMS, OLW. DEVICE IS NOT AVAILABLE FOR RETURN. WITHOUT 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. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. AN MDR WAS SUBMITTED AGAINST THE PC1Q. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE REPORT ID IS AVAILABLE. 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

    IT WAS REPORTED THAT, DURING INDUCTION, A VITAWAVE PLUS CUFF SHOWED DIFFERENT VALUES COMPARED TO AN ARM CUFF. FINGER CUFF VALUES WERE 146/63 (93) WHILE THE ARM CUFF READ 165/70 (106). AFTER A FEW ARM ADJUSTMENTS WERE MADE AND RECLIPPING THE PC1Q, THE FINGER CUFF VALUES WERE UPDATED TO 118/52 (75) AND THE ARM CUFF VALUES WERE 130/55 (80). PATIENT WAS UNDERGOING A SPINE PROCEDURE. BOTH CUFFS WERE NOT PLACED ON THE SAME ARM. IT IS UNKNOWN WHETHER THE INACCURATE VALUES WERE CAUSED BY THE VITAWAVE PLUS CUFF OR THE PC1Q. THERE WERE NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601750 VITAWAVE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES DR VWCA2 00690103219609

    Patients

    Seq Age Sex Outcome Treatment
    1