BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECG SLAVE CABLE

    MDR report key: 9709155 · Received February 13, 2020

    Report

    Report Number
    2015691-2020-10508
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 21, 2020
    Report Date
    January 21, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED BY THE LOCAL SERVICE PROVIDER THAT THE 64EKH CABLE IS NOT AN EDWARD¿S DEVICE. FURTHERMORE, EDWARD¿S TECHNICAL SERVICE CONFIRMED AS WELL THAT THE 64EKH CABLE IS NOT AN EDWARD¿S DEVICE. EDWARDS DOES NOT HAVE REPORTING RESPONSIBILITIES FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS AS WELL AS THE DEVICE HISTORY RECORD. 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 PART OF THIS MONTHLY REVIEW.

    Description of Event or Problem · 1

    AS REPORTED, DURING USE OF THIS 64 EKH SLAVE CABLE, THE HEMOSPHERE MONITOR PROVIDED DOUBLE HEART RATE VALUE THAN THE HEART RATE PROVIDED BY THE PHILIPS BEDSIDE MONITOR. THE VALUE PROVIDED BY THE BEDSIDE MONITOR WAS 70 BEATS/MIN APPROXIMATELY, WHILE THE HEMOSPHERE MONITOR DISPLAYED ROUGHLY TWICE THE VALUE (HR AROUND 140 BEATS/MIN). THERE WAS NO ERROR MESSAGE DISPLAYED. THE ISSUE WAS SOMETIMES SOLVED BY DISCONNECTING THE POWER CABLE FROM THE SOCKET AND LETTING THE MONITOR WORK IN BATTERY MODE. IN OTHER CASES, THE SWAN GANZ WAS JUST DISCONNECTED. AS PER NEW INFORMATION RECEIVED FROM THE USER, THE PROBLEM WAS FOUND TO BE RELATED TO THE 64 EKH SLAVE CABLE, WHICH HAD HIGH RESISTANCE. THE CABLE WAS REPLACED AND THE PROBLEM WAS SOLVED. THIS ISSUE HAS HAPPENED IN THE PAST AS WELL. THE HEMOSPHERE MONITOR FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173067 ECG SLAVE CABLE COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES 64EKH

    Patients

    Seq Age Sex Outcome Treatment
    1