BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAWAVE

    MDR report key: 23659487 · Received November 26, 2025

    Report

    Report Number
    2015691-2025-09609
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 8, 2025
    Report Date
    December 19, 2025
    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 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 MONITOR. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE REPORT ID IS AVAILABLE. PER INSTRUCTIONS FOR USE, "WARNING: IMPROPER PLACEMENT, SIZING, OR ALIGNMENT OF THE FINGER CUFF CAN LEAD TO INACCURATE MONITORING." 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

    REPORT WITH FDA REPORT ID NUMBER 2015691-2025-09617 WAS SUBMITTED FOR THE MONITOR THAT WAS USED DURING THE CASE. A DEVICE HISTORY RECORD CANNOT BE COMPLETED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING INDUCTION AND AFTER STAIRSTEPS, A VITAWAVE PLUS CUFF HAD NO WAVEFORM AND DIFFERENT PRESSURE VALUES COMPARED TO AN A-LINE. READINGS FROM THE VITAWAVE CUFF WAS 188/62 WHILE THE A-LINE READ 144/93. PHYSICIAN SWITCHED FINGERS BUT STILL STRUGGLED TO GET A WAVEFORM. AFTER REINITIALIZING THE PUMP A COUPLE OF TIMES, ISSUE WAS RESOLVED. IT IS UNKNOWN IF THE ISSUE WAS WITH THE FINGER CUFF OR MONITOR. THERE WAS NO PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813233 VITAWAVE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES DR VWCA2 00690103219609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown