BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAMARITAN AED PADS

    MDR report key: 565568 · Received January 8, 2005

    Report

    Report Number
    3004123209-2005-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2005
    Date of Event
    December 9, 2004
    Report Date
    January 8, 2005
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD. BELFAST, N.I. BY KATECHO INC.
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER INFORMED THE DISTRIBUTOR THAT THEY WERE TRYING TO USE THE DEFIBRILLATION PADS TO MONITOR THE ECG OF A PT. THE CUSTOMER STATED THAT WHEN THEY OPENED ONE SET OF PADS, ONE OF THE PADS COULD NOT BE PEELED PROPERLY FROM ITS RELEASE LINER. THEY STATED THAT THEY OPENED THE OTHER SET OF PADS, AND BOTH PADS COULD NOT BE EASILY PEELED FROM THEIR RELAESE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAMARITAN AED PADS DEFIBRILLATION ELECTRODES MLN HEARTSINE TECHNOLOGIES, LTD. BELFAST, N.I. BY KATECHO INC. SDE-201 Y042404

    Patients

    Seq Age Sex Outcome Treatment
    1 *