BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECG ELECTRODE

    MDR report key: 33424 · Received June 14, 1996

    Report

    Report Number
    MW4001344
    Event Type
    Malfunction
    Date Received
    June 14, 1996
    Report Date
    March 8, 1996
    Manufacturer
    VERMONT MEDICAL, INC.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON MARCH 7 AND AGAIN ON MARCH 8, WHILE ATTEMPTING TO DO AN EKG ON 2 SEPARATE PTS, THE PRINTOUT WAS A STRAIGHT LINE. ON BOTH OCCASIONS MEDICAL MAINTENANCE WAS CALLED TO CHECK OUT THE EKG MACHINE. THE MEDICAL MAINTENANCE TECH DETERMINED THAT THE PROBLEM WAS NOT THE EQUIPMENT, BUT THE ELECTRODES. THIS IS A MAJOR CONCERN AS ONE OF THESE PTS WAS A CHEST PAIN PT REQUIRING IMMEDIATE DIAGNOSING AND TREATMENT. TREATMENT NEEDED TO BE DETERMINED BY THE RESULTS OF AN EKG, THE MALFUNCTIONING OF THE ELECTRODES CAUSED A DELAY IN THE PT'S INITIAL TREATMENT AND SUBSEQUENT TRANSFER TO AN ER FOR DEFINITIVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECG ELECTRODE ECG ELECTRODE DRX VERMONT MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA