BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE VITA

    MDR report key: 24585372 · Received March 12, 2026

    Report

    Report Number
    2015691-2026-13161
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 20, 2026
    Report Date
    May 18, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXN
    UDI-DI
    00690103217124
    PMA / PMN Number
    K243781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELATED NON-CONFORMANCES WERE FOUND. 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. PRODUCT CODE; DSB, PRODUCT CODE NAME; PLETHYSMOGRAPH, IMPEDANCE. PRODUCT CODE; QMS, PRODUCT CODE NAME; ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER. PRODUCT CODE; DQE, PRODUCT CODE NAME; CATHETER, OXIMETER, FIBER-OPTIC. PRODUCT CODE; DQK, PRODUCT CODE NAME; COMPUTER, DIAGNOSTIC, PROGRAMMABLE. PRODUCT CODE; MUD, PRODUCT CODE NAME; OXIMETER, TISSUE SATURATION. PRODUCT CODE; FLL, PRODUCT CODE NAME; THERMOMETER, ELECTRONIC, CLINICAL. PRODUCT CODE; QAQ, ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, THAT THE CLEARSIGHT BLOOD PRESSURE (BP) WAS INACCURATE WHEN COMPARED TO THE OTHER "CNP BLOOD PRESSURE". THE BLOOD PRESSURES CONTINUED TO DROP TO 0/0 AND THEN STOP. THE USER RE-ZEROED THE HEMOSPHERE PRESSURE CONTROLLER KIT, WHICH TEMPORARILY CORRECTED THE ISSUE FOR A FEW MINUTES BUT THEN THE EVENT OCCURS AGAIN. THERE ARE NO ALLEGATIONS OF PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43529 HEMOSPHERE VITA SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN EDWARDS LIFESCIENCES HEMPC2K 600101042647 00690103217124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown