BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA

    MDR report key: 23589333 · Received November 18, 2025

    Report

    Report Number
    2015691-2025-09384
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 24, 2025
    Report Date
    November 18, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    QAQ
    UDI-DI
    00690103217957
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, QDK 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. IN ADDITION, A DEVICE HISTORY RECORD CANNOT BE COMPLETED WITHOUT A SERIAL NUMBER. IF THE DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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, THE BLOOD PRESSURE (BP) READINGS OBTAINED FROM AN ALTA MONITOR WAS SIGNIFICANTLY INCONSISTENT AND NOT CORRELATING WITH THE NON-INVASIVE BLOOD PRESSURE CUFF OR INVASIVE ARTERIAL LINE. MEAN ARTERIAL PRESSURE (MAP) VALUES, SYSTOLIC, AND DIASTOLIC VALUES WERE OFTEN VASTLY INACCURATE, EITHER MUCH HIGHER OR LOWER. PER REPRESENTATIVE, "THIS DISCREPANCY APPEARS TO RESOLVE ONLY WHEN THE PATIENT MONITOR IS ZEROED BEFORE ACUMEN IQ FINGER CUFF APPLICATION." THE FOLLOWING TROUBLESHOOTING WAS COMPLETED: VERIFIED CORRECT PATIENT CONNECTION AND PROPER CUFF PLACEMENT PER IFU, RECONNECTED FINGER CUFF AND RESTARTED THE MONITOR, COMPARED ACUMEN IQ READINGS TO NIBP AND/OR A-LINE READINGS, AND OBSERVED THAT ZEROING THE PATIENT MONITOR PRIOR TO CONNECTING IMPROVES CORRELATION TEMPORARILY WITH THE ALTA MONITOR. THERE WERE NO ALLEGATIONS OF PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862448 HEMOSPHERE ALTA ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR QAQ EDWARDS LIFESCIENCES ALTAALL1 00690103217957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown