BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000

    MDR report key: 22322408 · Received June 24, 2025

    Report

    Report Number
    2015691-2025-05150
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 31, 2025
    Manufacturer
    EDWARDS LIFE SCIENCES
    Product Code
    DSB
    UDI-DI
    00690103193473
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES: 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PRODUCT EVALUATION AS THE DEVICE WAS DISCARDED AND NOT RETURNED. WITHOUT ITS RETURN, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS THE COMPLAINT COULD NOT BE CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, THE STAFF NOTICED A BLOOD PRESSURE (BP) DIFFERENCE BETWEEN THE CLEARSIGHT AND NON-INVASIVE BLOOD PRESSURE. THE CLEARSIGHT CONSISTENTLY SHOWED LOW MEAN ARTERIAL PRESSURE (MAP) VS. SIMULTANEOUS NON-INVASIVE BLOOD PRESSURE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390915 EV1000 PLETHYSMOGRAPH, IMPEDANCE DSB EDWARDS LIFE SCIENCES PC2K 00690103193473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown