BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000

    MDR report key: 24206125 · Received January 28, 2026

    Report

    Report Number
    2015691-2026-10625
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 9, 2026
    Report Date
    March 20, 2026
    Manufacturer
    EDWARDS LIFESCIENCES IRVINE
    Product Code
    DSB
    UDI-DI
    00690103193473
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DXN- SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DQK- COMPUTER, DIAGNOSTIC, PROGRAMMABLE QAQ- ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR DXG- COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION. 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 PRESSURE CONTROLLER WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF INACCURATE VALUES WAS NOT ABLE TO BE CONFIRMED. WHEN CONNECTED TO A KNOWN WORKING HEMOSPHERE SYSTEM THIS PRESSURE CONTROLLER POWERED UP WITH NO FAULTS. WHEN CONNECTED TO A KNOWN WORKING HEART REFERENCE SENSOR IT ZEROED WITH NO FAULTS. WHEN A CUFF SIMULATOR WAS SET TO 120 OVER 80 THE CUFF 1 PORT GAVE READINGS OF 125 OVER 76 AND CUFF 2 GAVE READINGS OF 123 OVER 75. THIS IS WITHING THE SIMULATOR LIMITS. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS THE DEVICE NOT RETURNED AND NO DEFECT WAS FOUND, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE ASSOCIATED TO MANUFACTURING OR DESIGN COULD BE CONFIRMED. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING CAUTIONS: INACCURATE MEASUREMENTS CAN BE CAUSED BY IMPROPERLY ZEROED OR LEVELED SENSORS OR TRANSDUCERS, OVER OR UNDER DAMPED PRESSURE LINES, EXCESSIVE VARIATIONS IN BLOOD PRESSURES, EXCESSIVE PATIENT MOVEMENT OR ELECTROCAUTERY OR ELECTROSURGICAL UNIT INTERFERENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE PRESSURE CONTROLLER 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 70 POINTS DIFFERENT IN THE SYSTOLIC PRESSURE. FOR THE MAP THE DIFFERENCE COULD BE 10 UP TO 30 POINTS DIFFERENCE. THE PATIENT HAD A BRACHIAL OSCILLOMETRIC CUFF ON. IT WAS ON THE OPPOSITE ARM THEN IT WAS MOVED TO THE SAME SIDE AS THE ACUMEN CUFF. REPLACING THE PRESSURE CONTROLLER FOR ANOTHER ONE RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267713 EV1000 PLETHYSMOGRAPH, IMPEDANCE DSB EDWARDS LIFESCIENCES IRVINE PC2K 600101036085 00690103193473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown