BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000

    MDR report key: 22136725 · Received June 3, 2025

    Report

    Report Number
    2015691-2025-04388
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 17, 2025
    Manufacturer
    EDWARDS LIFESCIENCES IRVINE
    Product Code
    DSB
    UDI-DI
    00690103193473
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. 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 PRESSURE CONTROLLER WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF INACCURATE VALUES WAS NOT CONFIRMED. THE DEVICE WAS CONNECTED TO A KNOWN WORKING HEMOSPHERE SYSTEM AND MONITORED A CUFF SIMULATOR FOR OVER AN HOUR. THE READINGS WERE ACCURATE AND CONSISTENT. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. SINCE THE COMPLAINT AFFECTED UNIT WAS RETURNED FOR EVALUATION AND NO DEFECT WAS FOUND, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE ASSOCIATED TO MANUFACTURING OR DESIGN COULD NOT BE CONFIRMED. THE INSTRUCTIONS FOR USE STATES PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: DO NOT OVERTIGHTEN THE PRESSURE CONTROLLER BAND. DO NOT APPLY PRESSURE CONTROLLER BAND ON INJURED SKIN AS THIS CAN CAUSE FURTHER INJURY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SET UP OF THE PRESSURE CONTROLLER KIT, IT WAS GIVING INCONSISTENT READINGS. THE REP EXCHANGED THE DEVICE FOR A NEW ONE AND THE ISSUE RESOLVED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778150 EV1000 PLETHYSMOGRAPH, IMPEDANCE DSB EDWARDS LIFESCIENCES IRVINE PC2K 600101039403 00690103193473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown