BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4792678 · Received May 18, 2015

    Report

    Report Number
    3004123209-2015-00565
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Date of Event
    May 12, 2015
    Report Date
    June 25, 2015
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN MARCH 2010 AND PERFORMED TO SPECIFICATION UP TO THE 4TH AUGUST 2013. MULTIPLE MANUAL POWER UPS OF TEN MINUTES DURATION WERE OBSERVED IN THE DEVICE MEMORY BETWEEN (B)(4) 2013 AND (B)(4) 2014. THE PAD-PAK WAS REMOVED FROM THE DEVICE. THE DEVICE FAILED MULTIPLE SELF-TESTS DUE TO A LOW BATTERY BETWEEN 15TH-18TH MARCH 2015. UPON VISUAL INSPECTION OF THE DEVICE THE APEX PATIENT POGO PIN WAS SEEN TO BE SHEARED OFF. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE DAMAGE TO THE POGO-PIN MAY HAVE OCCURRED DURING THE REINSTALLATION OF THE PAD-PAK ON 15TH MARCH 2015 AND SUBSEQUENTLY RESULTED IN THE LOW BATTERY WARNING DUE TO AN INCORRECTLY SEATED PAD-PAK. NO PAD-PAK WAS RETURNED FOR INVESTIGATION. 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 WAS MALFUNCTIONED AS THE DEVICE RED STATUS INDICATOR FLASHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321246 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1