BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKG ELECTRODE

    MDR report key: 43148 · Received October 17, 1996

    Report

    Report Number
    MW1010076
    Event Type
    Malfunction
    Date Received
    October 17, 1996
    Date of Event
    September 24, 1996
    Report Date
    October 4, 1996
    Manufacturer
    GRAPHIC CONTROLS CORP.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NO EKG DISPLAY ON MONITOR. PT CABLE AND EKC MODULE CHANGED, BUT PROBLEM NOT CORRECTED. ELECTRODES CHANGED X3, BUT STILL NO EKG. REPLACED ELECTRODES WITH ANOTHER BRAND AND PROBLEM CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EKG ELECTRODE EKG ELECTRODE DRX GRAPHIC CONTROLS CORP. * F0276 1 02 185

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR