BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAWAVE

    MDR report key: 23891135 · Received December 24, 2025

    Report

    Report Number
    2015691-2025-10591
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    December 10, 2025
    Report Date
    December 26, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DQK
    UDI-DI
    00690103219609
    PMA / PMN Number
    K243781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT WITH FDA REPORT ID: 2015691-2025-10597 WAS SUBMITTED FOR THE PC1Q THAT WAS USED DURING THE CASE.

    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 USE, A VITAWAVE CUFF HAD INACCURATE READINGS WHILE CONNECTED TO A VITA MONITOR AND PC1Q CABLE IN A EP PFA CASE. THE VITAWAVE PLUS CUFF WAS PLACED ON THE PATIENT'S MIDDLE RIGHT FINGER. THE NON INVASIVE BLOOD PRESSURE CUFF (NIBP) WAS READING SYSTOLIC/DIASTOLIC IN THE 180/110 WHILE THE FINGER CUFF WAS READING LOWER, PARTICULARLY THE DIASTOLIC PRODUCING A MAP THAT WAS 30 MMHG LOWER THAN THE NIPB. THERE WERE MODERATE VASOCONSTRICTION WARNINGS. THE CUFF WAS THEN PLACED ON THE RING FINGER AND RESTARTED. THE PHYSICAL REACHED 60-70 HOWEVER THE SQI WAS 1 BAR FOR SOME TIME. TOWARDS THE END OF THE CASE, THE FINGER CUFF EVENTUALLY CORRELATED BETTER TO THE SYSTOLIC BUT THE DIASTOLIC WAS STILL LOWER WITH THE MAP OFF BY 10-15MMHG. FINGER CUFF WAS NOT PLACED ON THE SAME ARM AS THE NIBP. NIBP CUFF WAS SET TO DO READINGS EVERY 5 THEN 3 DUE TO DISCREPANCY. CLINICIANS TREATED TO THE BRACHIAL ARM CUFF. IT IS UNKNOWN WHETHER ISSUE WAS CAUSED BY THE FINGER CUFF OR PC1Q CABLE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766016 VITAWAVE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES DR VWCA2 00690103219609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown