BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA

    MDR report key: 23659549 · Received November 26, 2025

    Report

    Report Number
    2015691-2025-09610
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 7, 2025
    Report Date
    February 12, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQE
    UDI-DI
    00690103217964
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 NOT BEEN 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

    THE DEVICE HISTORY RECORD REVIEW HAS BEEN COMPLETED. NO RELATED NON-CONFORMANCES WERE FOUND. NO ESCALATION REQUIRED. THE SUSPECT DEVICE WAS EVALUATED BY OUR PRODUCT EVALUATION AND TEAM AND THE REPORTED EVENT COULD NOT BE CONFIRMED.. AS THE COMPLAINT COULD NOT BE CONFIRMED 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 VOICE OF THE CUSTOMER THERE IS NOT SUFFICIENT EVIDENCE TO SUGGEST THAT THE DEVICE RELATED ISSUE RESULTED FROM ANY OF THE SPECIFIED FACTORS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE HEMOSPHERE ALTA SYSTEM WITH CLEARSIGHT DISPLAYED A SUBSYSTEM FAILURE ALERT. THE END USER RESTARTED THE DEVICE AND CLEARED THE ALERT; HOWEVER, SUBSEQUENT MEASUREMENTS SHOWED VARIATIONS IN BLOOD PRESSURE (BP) AND PULSE RATE (PR). THE ISSUE COULD NOT BE RESOLVED EVEN AFTER REPLACING THE PC2K MODULE. ADDITIONAL FOLLOW-UP EFFORTS HAVE FOCUSED ON DETERMINING PATIENT INVOLVEMENT AND WHETHER ANY INJURY OR HARM OCCURRED AS A RESULT OF THE REPORTED EVENT. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131310 HEMOSPHERE ALTA CATHETER, OXIMETER, FIBER-OPTIC DQE EDWARDS LIFESCIENCES ALTASR1 19Y0001587 00690103217964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown