BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA

    MDR report key: 23589428 · Received November 18, 2025

    Report

    Report Number
    2015691-2025-09385
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 29, 2025
    Report Date
    January 28, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    QAQ
    UDI-DI
    00690103217957
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: DQE, DSB, DXN, FLL, MUD, QMS, QNL, DQK ADDITIONAL PREMARKET SUBMISSION: K242451 THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS 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

    A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED MONITOR. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE "START SWAN-GANZ" ICON WAS AVAILABLE AND ABLE TO BE STARTED. TRS13 SWAN INTERFACE TESTS ALSO PASSED ON THE FUNCTIONAL TESTER. NO DAMAGE WAS FOUND. AN ENGINEERING EVALUATION COULD NOT BE COMPLETED ON THE PRODUCT AS THERE WAS NO DEFECT FOUND, BUT A DEVICE HISTORY RECORD WAS REVIEWED ON THE REPORTED SERIAL NUMBER. PER THE REVIEW, PRODUCT PASSED WITHOUT NONCONFORMANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, THE CARDIAC OUTPUT AND CARDIAC INDEX WAS INCORRECT ON THE HEMOPSHERE ALTA ALL 1 MONITOR. THE CABLE WAS CHANGED OUT BUT THE ISSUE CONTINUED. THE PHYSICIAN LOST CONFIDENCE IN THIS PARTICULAR MONITOR. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY OR HARM ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275049 HEMOSPHERE ALTA ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR QAQ EDWARDS LIFESCIENCES ALTAALL1 19Y0002099 00690103217957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown