BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA

    MDR report key: 22856503 · Received August 20, 2025

    Report

    Report Number
    2015691-2025-06864
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 20, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    QAQ
    UDI-DI
    00690103217957
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED. WITHOUT THE 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. HOWEVER, AN INVESTIGATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE SERIAL NUMBER. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETE. PRODUCT EVALUATION WILL BE INCLUDED IN THE SUPPLEMENTAL REPORT IF DEVICE IS RETURNED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, AN ALTA MONITOR DISPLAYED INACCURATE CARDIAC OUTPUT, STROKE VOLUME, CENTRAL VENOUS PRESSURE, STO2, AND SYSTEMIC VASCULAR RESISTANCE VALUES. THE MONITOR ALERTS WERE NOT AUDIBLE EVEN THOUGH IT WAS ACTIVATED IN THE SETTINGS AND NO ALERTS WERE DISPLAYED. ISSUE WAS RESOLVED BY RESTARTING THE MONITOR. THERE WERE NO ALLEGATION OF PATIENT INJURIES. PATIENT DEMOGRAPHICS ARE NOT AVAILABLE. FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189723 HEMOSPHERE ALTA ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR QAQ EDWARDS LIFESCIENCES ALTAALL1 19Y0000218 00690103217957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown