BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4792701 · Received May 18, 2015

    Report

    Report Number
    3004123209-2015-00572
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Date of Event
    May 13, 2015
    Report Date
    August 17, 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
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN (B)(6) 2009 AND PERFORMED TO SPECIFICATION UP TO (B)(6) 2011. THE DEVICE RECORDED TEMPERATURES OUTSIDE THE RECOMMENDED OPERATING TEMPERATURE. THE DEVICE FAILED MULTIPLE SELF-TESTS DUE TO A LOW BATTERY BETWEEN (B)(6) 2011 AND (B)(6) 2012. THE DEVICE REMAINED IN FAULT MODE UNTIL (B)(6) 2013 WHEN A FRESH PAD-PAK WAS INSTALLED AND THE DEVICE PASSED A SELF-TEST. MULTIPLE MANUAL POWER UPS MAINLY, OF TEN MINUTES DURATION, WERE OBSERVED IN THE DEVICE MEMORY BETWEEN (B)(6) 2014 AND THE LAST LOG ENTRY ON (B)(6) 2015. IT IS REASONABLE TO CONCLUDE THAT DEVICES RETURNED FOR THE REPORTED FAULT MAY BE ATTRIBUTED TO MEMBRANE FAILURE DUE TO ADVERSE STORAGE CONDITIONS. THE TEN MINUTE TIME OUTS WOULD SUGGEST A FAILING MEMBRANE. 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 PAD UNIT POWERS ON WITHOUT MANUAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321179 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1