BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA

    MDR report key: 24328911 · Received February 12, 2026

    Report

    Report Number
    2015691-2026-11064
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 26, 2026
    Report Date
    April 27, 2026
    Manufacturer
    EDWARDS LIFE SCIENCES
    Product Code
    DQK
    UDI-DI
    00690103217964
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDA PRODUCT CODES: DSB PLETHYSMOGRAPH, IMPEDANCE DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE FLL THERMOMETER, ELECTRONIC, CLINICAL MUD OXIMETER, TISSUE SATURATION QAQ ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR QEM CEREBRAL OXIMETER 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. THE DEVICE HISTORY RECORD REVIEW HAS BEEN COMPLETED. NO RELATED NON-CONFORMANCES WERE FOUND. NO ESCALATION REQUIRED. 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

    ONE HEMOSPHERE ALTA WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT WAS UNABLE TO BE CONFIRMED. THE UNIT WAS MONITORED USING CLEARSIGHT TECHNOLOGY FOR TWO HOURS AND THE FAULT: CLEARSIGHT SYSTEM AIR SUPPLY ERROR, INSUFFICIENT PRESSURE BUILD UP ERROR NEVER DISPLAYED. THE MAP AND BP READINGS WERE ACCURATE AND STABLE FOR THE ENTIRE TWO HOURS. NO DAMAGE WAS FOUND. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE COMPLAINT AFFECTED UNIT WAS RETURNED FOR EVALUATION AND NO DEFECT WAS FOUND. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE ALLEGED COMPLAINT IS UNABLE TO BE DETERMINED AT THIS TIME. THERE WAS NO EVIDENCE OF PRODUCT NONCONFORMANCE OR LABELING/IFU INADEQUACIES IDENTIFIED. THE PURPOSE OF THE ROOT CAUSE ANALYSIS IS TO DETERMINE IF THE DEVICE RELATED ISSUE RESULTED FROM: INCORRECT/INADEQUATE LABELING/IFU/TRAINING MANUAL, USE ERROR, OR PATIENT/PROCEDURAL FACTORS. BASED ON THE VOC THERE IS NOT SUFFICIENT EVIDENCE TO SUGGEST THAT THE DEVICE RELATED ISSUE RESULTED FROM ANY OF THE SPECIFIED FACTORS. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH AN ELECTRICAL INSPECTION PROCESS. COMPLAINTS INCIDENCE WILL CONTINUE TO BE MONITORED, AND APPLICABLE ACTIONS WILL BE TAKEN AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, THE HEMOSPHERE ALTA MONITOR EXPERIENCED SIGNIFICANT MEAN ARTERIAL PRESSURE (MAP) VARIABILITY WHEN USING CLEARSIGHT. SPECIFICALLY, ARTERIAL LINE CORRELATION DRIFTING BY 20 TO 40 MMHG. IT WAS ALSO NOTED THAT THE SUSPECT DEVICE EXPERIENCED FAULT: CLEARSIGHT SYSTEM AIR SUPPLY ERROR AND INSUFFICIENT PRESSURE BUILD UP. THERE ARE NO ALLEGATIONS OF PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524547 HEMOSPHERE ALTA COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFE SCIENCES ALTASR1 19Y0000392 00690103217964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown