BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAWAVE

    MDR report key: 23891147 · Received December 24, 2025

    Report

    Report Number
    2015691-2025-10592
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    December 17, 2025
    Report Date
    February 4, 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

    ADDITIONAL PRODUCT CODE: DQE, QAQ, MUD, DXN, DSB, FLL, QMS, OLW. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISPOSED. 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. IN ADDITION, A DEVICE HISTORY RECORD CANNOT BE COMPLETED WITHOUT A LOT NUMBER. REPORT WITH FDA REPORT ID NUMBER 2015691-2026-10425 WAS SUBMITTED FOR THE PC1Q THAT WAS USED DURING THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, A VITAWAVE CUFF WITH A PC1Q WAS NOT CORRELATING WITH THE BLOOD PRESSURE CUFF. THE FINGER CUFF AND CABLE SET DISPLAYED LOWER THAN NORMAL DIASTOLIC BLOOD PRESSURES. BOTH DEVICES WERE CONNECTED TO A HEMOSPHERE STEAM. THERE WAS NO PATIENT HARM. IT IS UNKNOWN IF THE CUFF OR CABLE CAUSED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149826 VITAWAVE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES DR VWCA2 00690103219609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown