BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDICAL DATA ELECTRONICS

    MDR report key: 118796 · Received September 8, 1997

    Report

    Report Number
    118796
    Event Type
    Other
    Date Received
    September 8, 1997
    Date of Event
    August 25, 1997
    Manufacturer
    MEDICAL DATA ELECTRONICS
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER CHARGED THE DEFIBRILLATOR AND NOT SEEING ANY LABELLING ON THE FRONT PANEL ATTEMPTED TO DISCHARGE USING THE "INTERNAL DISCHARGE" BUTTON. R2 PADS AND MDE CABLE WAS ATTACHED. NO DISCHARGE OCCURRED. WITHIN 20 SECONDS THE USER REALIZED THAT SHE MUST PRESS THE BUTTONS ON THE CABLE BOX TO DISCHARGE. THE DEFIBRILLATOR WAS THEN SUCCESSFULLY DISCHARGED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL DATA ELECTRONICS Implant DEFIBRILLATOR/HANDS FREE PADS MLN MEDICAL DATA ELECTRONICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other