BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 164811 · Received November 12, 1997

    Report

    Report Number
    MW4002200
    Event Type
    Malfunction
    Date Received
    November 12, 1997
    Report Date
    October 9, 1997
    Manufacturer
    VERMONT MEDICAL INC.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADHESIVE ON THESE ELECTRODES DOES NOT STICK AS WELL AS OTHERS. IT IS IMPERATIVE THAT ELECTRODES STICK TO THE PTS BEING MONITORED, OTHERWISE THE MONITORS DO NOT GIVE THE PROPER READINGS. THE PTS THAT ARE MONITORED ARE SEDATED FOR ORAL SURGERY AND ANY FLUCTUATIONS IN VITALS MUST BE NOTED, CURRENTLY THIS IS NOT HAPPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ELECTRODE ECG, DISPOSABLE 30'S DRX VERMONT MEDICAL INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO VITAL SIGNS MONITOR