BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE VITA

    MDR report key: 23559608 · Received November 14, 2025

    Report

    Report Number
    2015691-2025-09288
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 22, 2025
    Report Date
    February 4, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXN
    UDI-DI
    00690103218855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: DSB, QMS, DQE, DQK, MUD, FLL, QAQ, OLW. MONITOR WILL NOT BE RETURNED SO A PRODUCT EVALUATION CANNOT BE COMPLETED. HOWEVER, AN INVESTIGATION WAS INITIATED TO EVALUATE THE PROVIDED DIAGNOSTIC LOGS. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETE. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE VITAWAVE FINGER CUFF: DO NOT APPLY FINGER CUFF(S) ON A HAND OR FINGER WHEN A SECOND BLOOD PRESSURE MEASUREMENT DEVICE IS ACTIVELY MONITORING ON THE SAME ARM (OR HAND OR FINGER). 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 NOT RETURNED, HOWEVER AN EVALUATION WAS COMPLETED ON THE PROVIDED DATA LOGS. LOGS WERE REVIEWED AND THE REPORT OF INACCURATE VALUES COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING OR DESIGN DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, A VITA MONITOR HAD SIGNIFICANT MEAN ARTERIAL PRESSURE VALUE DIFFERENCE COMPARED TO A BRACHIAL CUFF. A 20 TO 30 MMHG DIFFERENCE WAS CONSISTENT THROUGHOUT THE CASE. A VITAWAVE CUFF WAS CONNECTED TO THE VITA MONITOR. BOTH CUFFS WERE PLACED ON THE SAME ARM AND AT THE SAME RELATIVE HEIGHT. BRACHIAL CUFF WAS SET TO READ EVERY 5 MINUTES. IT WAS NOTED THAT THE ISSUE WAS RELATED TO THE VITA MONITOR SOFTWARE OR THE BRACHIAL CUFF. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2805323 HEMOSPHERE VITA SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN EDWARDS LIFESCIENCES HEMVITA1 53800185 00690103218855

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown