BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT/CHILD, RADIOLUCENT, LEADS OUT, DEFIB ELECTRODES W/ PHILLIPS CONNECTOR

    MDR report key: 7540199 · Received May 24, 2018

    Report

    Report Number
    7540199
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    May 14, 2018
    Report Date
    May 21, 2018
    Manufacturer
    HEART SYNC INC
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A MOCK CODE, IT WAS FOUND THAT IF THE PAPER BACKING FROM THE DEFIBRILLATOR PADS WERE REMOVED INCORRECTLY (I.E. FROM THE OPPOSITE END, INSTEAD OF THE "PEEL HERE ONLY") THE CONDUCTION GEL CAN BE REMOVED WITH THE PAPER. WITHOUT THE CONDUCTION GEL, THE PATCH MAY BE UNABLE TO ASSESS CARDIAC RHYTHM OR DELIVER A SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384604 ADULT/CHILD, RADIOLUCENT, LEADS OUT, DEFIB ELECTRODES W/ PHILLIPS CONNECTOR ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION MLN HEART SYNC INC T100LOAC-PHILIPS Y020918-01

    Patients

    Seq Age Sex Outcome Treatment
    1