BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3002148 · Received February 11, 2013

    Report

    Report Number
    3004123209-2013-00469
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    October 16, 2011
    Report Date
    January 21, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2009 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2011. ON (B)(6) 2011 THE DEVICE FAILED A WEEKLY SELF TEST DUE TO A LOW BATTERY. ON (B)(6) 2011 THE USER PERFORMED 3 MANUAL SELF TESTS. THE FIRST 2 FAILED FOR A LOW BATTERY, THE 3RD PASSED. THIS PATTERN CONTINUED UNTIL (B)(6) 2012 WHEN A NEW PAD-PAK WAS INSERTED. THE DEVICE THEN PERFORMED SUCCESSFULLY UNTIL (B)(6) 2012. ON THIS DATE THE DEVICE FAILED DUE TO A LOW BATTERY. ON (B)(6) 2012 THE DEVICE FAILED A MANUAL TEST. A NEW PAD-PAK WAS INSTALLED AND THE DEVICE PASSED A SELF TEST. THE HISTORY LOG WOULD SUGGEST THE USER WAS ALTERNATING BETWEEN NEW AND OLD PAD-PAKS. NO FAULTS WAS FOUND WITH THE RETURNED PAD DEVICE OR PAD-PAKS. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE STATUS INDICATOR CHANGES FROM RED TO GREEN. A DEVICE IN THIS FAULT MODE, IF 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
    59536 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1