BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA

    MDR report key: 24845637 · Received April 10, 2026

    Report

    Report Number
    2015691-2026-14061
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 10, 2026
    Manufacturer
    EDWARDS LIFESCIENCES IRVINE
    Product Code
    DQE
    UDI-DI
    00690103217957
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DSB, PLETHYSMOGRAPH, IMPEDANCE. DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. FLL- THERMOMETER, ELECTRONIC, CLINICAL. MUD, OXIMETER, TISSUE SATURATION. QAQ, ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. QMS, ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER. QNL, MEDIUM-TERM ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. DQK, COMPUTER, DIAGNOSTIC, PROGRAMMABLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE ALTA MONITOR, DURING A DEMO, THE CLEARSIGHT CUFF WAS SHOWING MEASUREMENTS 20 POINTS LOWER THAN THE ARM CUFF. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334356 HEMOSPHERE ALTA CATHETER, OXIMETER, FIBER-OPTIC DQE EDWARDS LIFESCIENCES IRVINE ALTAALL1 19Y0000694 00690103217957

    Patients

    Seq Age Sex Outcome Treatment
    1