BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA

    MDR report key: 23139652 · Received September 24, 2025

    Report

    Report Number
    2015691-2025-07864
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 5, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQE
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. 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. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    ONE HEMOSPHERE ALTA MONITOR WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF INACCURATE VALUES WAS UNABLE TO BE CONFIRMED. A PC2K, HRS AND CUFF SIMULATOR WERE CONNECTED TO THE CSM MODULE. NORMAL BP READINGS AND WAVEFORM WERE ABLE TO BE OBTAINED. MONITORED FOR 1 HOUR WITHOUT ANY ISSUES. NO DAMAGE WAS FOUND. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. SINCE THERE WAS NO EVIDENCE OF PRODUCT NONCONFORMANCE A ROOT CAUSE IS UNABLE TO 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE ALTA MONITOR A "FAULT: CLEARSIGHT SYSTEM - SUBSYSTEM MALFUNCTION - SERVICING REQUIRED" ERROR MESSAGE APPEARED. PRIOR TO THE ERROR, THE UNIT INITIALLY WAS READING BLOOD PRESSURES MUCH LOWER THAN A RADIAL ARTERIAL LINE. 64/18 WHEN THE ARTERIAL LINE SHOWED 94/54. THEN THE CLEARSIGHT CUT OUT AND SHOWED THE ERROR AND WOULD NOT LET THE USER RESUME MONITORING. TURNED MONITOR OFF AND ON, THE PRESSURES WERE STILL SIGNIFICANTLY LOWER. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642257 HEMOSPHERE ALTA CATHETER, OXIMETER, FIBER-OPTIC DQE EDWARDS LIFESCIENCES ALTASR1 19Y0001325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown