BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE VITA

    MDR report key: 23659281 · Received November 26, 2025

    Report

    Report Number
    2015691-2025-09606
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 16, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXN
    UDI-DI
    00690103218855
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE DEVICE HISTORY RECORD REVIEW HAS NOT BEEN COMPLETED. 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. D2B. ADDITIONAL DEVICE PRODUCT CODES: DSB, QMS, DQE, DQK, MUD, FLL, QAQ, OLW.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PRODUCT EVALUATION AS THE DEVICE WAS NOT RETURNED. WITHOUT ITS RETURN, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS THE COMPLAINT COULD NOT BE CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. AS PART OF THE MANUFACTURING PROCESS 100 PERCENT OF THE UNITS GO THROUGH A BALLOON INSPECTION PROCESS. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE HEMOSPHERE VITA MONITOR, THE VITAWAVE CUFF (VW) WAS NOT CORRELATING TO THE ARTERIAL LINE (AL). VW SYSTOLIC PRESSURE WAS +15 AND MAP WAS +10 . THE PC1Q WAS UNCLIPPED SO IT WOULD HANG DOWN AND WIGGLED, THEN RE-CLIPPED. THE HEMOSPHERE VITA MONITOR WAS RESTARTED, AND THEN VW CUFF AND A-LINE CORRELATED VW=121/63 (86), AL=117/66 (87). THERE WAS NO ALLEGATION OF PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538611 HEMOSPHERE VITA SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN EDWARDS LIFESCIENCES HEMVITA1 53800020 00690103218855

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown