BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 24206120 · Received January 28, 2026

    Report

    Report Number
    2015691-2026-10623
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 9, 2026
    Report Date
    March 2, 2026
    Manufacturer
    EDWARDS LIFESCIENCES IRVINE
    Product Code
    DQK
    UDI-DI
    00690103202762
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DQE- CATHETER, OXIMETER, FIBER-OPTIC QAQ- ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR MUD- OXIMETER, TISSUE SATURATION DSB- PLETHYSMOGRAPH, IMPEDANCE QMS- ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER FLL- THERMOMETER, ELECTRONIC, CLINICAL DXN- SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE OLW- INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE 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.

    Additional Manufacturer Narrative · 0

    ONE HEMOSPHERE CLEARSIGHT MODULE WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF INACCURATE VALUES WAS NOT CONFIRMED. ENGINEERING CONNECTED THE HEMCSM10 TO A KNOWN WORKING HEM1 HOT MOCK-UP SYSTEM. THE HEMCSM10 CAUSED NO ERRORS. IT WAS ALSO ABLE TO OBTAIN NORMAL BP READINGS AND WAVEFORM. MONITORED FOR 1 HOUR AND THE BLOOD PRESSURE READINGS REMAINED STABLE FOR THE DURATION. NO PHYSICAL DAMAGE WAS FOUND. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT ANY NONCONFORMANCES. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS NO DEFECT WAS FOUND WITH THE DEVICE, THE ROOT CAUSE OF THE ALLEGED COMPLAINT IS UNABLE TO BE DETERMINED AT THIS TIME NOR IS THERE EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING CAUTIONS: INACCURATE MEASUREMENTS CAN BE CAUSED BY EXCESSIVE VARIATIONS IN BLOOD PRESSURE, POOR BLOOD CIRCULATION IN FINGERS, EXCESSIVE PATIENT MOVEMENT, INCORRECT PLACEMENT OF FINGER CUFF, OR A BENT CUFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE CLEARSIGHT MODULE IT WAS PROVIDING LOW SYSTOLIC AND MAP PRESSURE VALUES COMPARED TO THE ARTERIAL AND BRACHIAL MEASUREMENTS ON THE PATIENTS BEDSIDE GE MONITOR. THE VALUES RANGED ANYWHERE FROM 10 TO 30 POINTS DIFFERENT IN THE SYSTOLIC PRESSURE. FOR THE MAP THE DIFFERENCE COULD BE 10 UP TO 20 POINTS DIFFERENCE. THE PATIENT HAD A BRACHIAL OSCILLOMETRIC CUFF ON THE SAME SIDE AS THE ACUMEN CUFF. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340394 HEMOSPHERE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES IRVINE HEMCSM10 16803073 00690103202762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown