BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 24210498 · Received January 29, 2026

    Report

    Report Number
    2015691-2026-10639
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 12, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQK
    UDI-DI
    00690103197006
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDA PRODUCT CODES: DSB PLETHYSMOGRAPH, IMPEDANCE DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE FLL THERMOMETER, ELECTRONIC, CLINICAL MUD OXIMETER, TISSUE SATURATION, QAQ ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR, QEM CEREBRAL OXIMETER, QMS ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER, QNL MEDIUM-TERM ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE WAS NO PRODUCT EVALUATION AS THE DEVICE WAS DISCARDED AND 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. 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, THE HEMOSPHERE 1 MONITOR DISPLAYED ERRONEOUS VALUES WHILE CONNECTED TO THE FLOTRAC DEVICE. THE TROUBLESHOOTING STEPS TAKEN AT THE TIME OF THE EVENT ARE UNKNOWN. BIOMEDICAL ENGINEERING ALSO NOTED THAT THE UNIT HAS A HEMOSPHERE SWAN-GANZ MODULE LODGED INSIDE, AND THE RELEASE BUTTON APPEARS TO BE JAMMED. THERE ARE NO ALLEGATIONS OF PATIENT INJURY OR HARM ASSOCIATED WITH THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51997 HEMOSPHERE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES HEM1 13823453 00690103197006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown