BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA

    MDR report key: 23352285 · Received October 21, 2025

    Report

    Report Number
    2015691-2025-08706
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 11, 2025
    Manufacturer
    EDWARDS LIFESCIENCES IRVINE
    Product Code
    DQE
    UDI-DI
    00690103217957
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE HEMOSPHERE ALTA ALL-ON-ONE MONITOR WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF INACCURATE VALUES WAS NOT CONFIRMED. MONITORED SVO2 FOR AN HOUR. THE READING REMAINED STEADY AT 80%. MONITORED FOR 1 HOUR USING CLEARSIGHT. READINGS AND WAVEFORM WERE STEADY THE ENTIRE TIME. NO ERRORS OR ALARMS OCCURRED. NO DAMAGE WAS FOUND. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. SINCE THERE WAS NO DEFECT FOUND, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT AND NO ROOT CAUSE CAN BE DETERMINED. THE IFU CONTAINS THE FOLLOWING PRECAUTIONS: INACCURATE CARDIAC OUTPUT MEASUREMENTS MAY BE CAUSED BY INCORRECT PLACEMENT OR POSITION OF THE CATHETER, ANATOMICAL ABNORMALITIES, EXCESSIVE PATIENT MOVEMENT, OR ELECTROCAUTERY OR ELECTROSURGICAL UNIT INTERFERENCE.

    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 ALL IN ONE, AN UNPROMPTED HIGH-PITCHED ALARM OCCURRED DURING THE CASE. THE TOUCHSCREEN FROZE, ARTERIAL LINE PRESSURE DISAPPEARED FROM THE ANESTHESIA MONITOR, AND SVO2 READ APPROXIMATELY 30 POINTS LOWER THAN EXPECTED. REBOOTING THE MONITOR RESTORED FUNCTION, BUT THE SVO2 READING REMAINED INACCURATE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234742 HEMOSPHERE ALTA CATHETER, OXIMETER, FIBER-OPTIC DQE EDWARDS LIFESCIENCES IRVINE ALTAALL1 19Y0000346 00690103217957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown