BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3002128 · Received February 11, 2013

    Report

    Report Number
    3004123209-2013-00482
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 24, 2010
    Report Date
    January 21, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2009 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2010. THE PAD-PAK WAS REMOVED ON THIS DAY. ON (B)(6) 2010, A PAD-PAK WAS INSTALLED WITH THE DEVICE PASSING A SELF TEST AND OPERATED TO SPEC UNTIL (B)(6) 2012. ON (B)(6) 2012, THE DEVICE FAILS A WEEKLY SELF TEST DUE TO A LOW BATTERY. ON (B)(6) 2012, A FRESH PAD-PAK IS INSERTED AND THE DEVICE PASSED A SELF TEST. THE PROBLEM WITH THE DEVICE NOT POWERING ON WAS CAUSED BY THE POSITIVE TERMINAL POGO-PIN NOT MAKING CONTACT WITH THE PAD-PAK BECAUSE IT WAS DAMAGED. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE DEVICE WOULD NOT POWER-ON AND THERE IS NO STATUS INDICATOR. A DEVICE IN THIS FAULT MODE, IT LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEVICE TO PERFORM AS INTENDED IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60379 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1