BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 24585382 · Received March 12, 2026

    Report

    Report Number
    2015691-2026-13165
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 18, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQK
    UDI-DI
    00690103197006
    PMA / PMN Number
    K243781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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-CONFORMANCE'S 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: PRODUCT CODE NAME: DQE, CATHETER, OXIMETER, FIBEROPTIC, QAQ, ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR, MUD, OXIMETER, TISSUE SATURATION, DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, DSB, PLETHYSMOGRAPH, IMPEDANCE, QMS, ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER, FLL, THERMOMETER, ELECTRONIC, CLINICAL, OLW, INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, THE HEMOSPHERE 1 MONITOR SHOWED HIGH CARDIAC OUTPUT (CO) AND CARDIAC INDEX (CI) THAT DID NOT CORRELATE WITH THE PATIENT'S CONDITIONS. THE CLINICIAN CHANGED ALL TRUNK CABLES BUT THE ISSUE DID NOT RESOLVE. HE THEN SWAPPED TO A NEW MONITOR, AND THE REPORTED ISSUE WAS RESOLVED. THERE WAS NO ALLEGATION OF PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279353 HEMOSPHERE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES HEM1 13825064 00690103197006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown