BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932517 · Received January 23, 2013

    Report

    Report Number
    3004123209-2012-00454
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 4, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER ON (B)(6) 2010 AND PERFORMED TO SPECIFICATION UP TO (B)(6) 2010. THERE WAS NO HISTORY OF THE DEVICE PERFORMANCE BETWEEN (B)(6) 2012, WHICH WOULD INDICATE THAT THE PAD-PAK HAD BEEN REMOVED FROM THE DEVICE DURING THIS TIME PERIOD. THE INFORMATION OBTAINED FROM THE DEVICE SHOWED THAT ON THE (B)(6) 2012 THE DEVICE FAILED A MANUAL TEST DUE TO A "SHOCK KEY ERROR". THE DEVICE CORRECTLY SWITCHED TO FAULT MODE WITH THE STATUS INDICATOR FLASHING RED AND THE DEVICE ISSUING THE AUDIBLE WARNING MESSAGE. INVESTIGATION CONFIRMED THERE TO BE A FAULT WITH THE DEVICE MEMBRANE. THERE WAS EVIDENCE OF CORROSION ON THE DEVICE, WHICH WERE NOTABLE ON THE MEMBRANE TAIL. THE CORROSION WOULD HAVE CONTRIBUTED TO THE FAILURE OF THE DEVICE MEMBRANE. CORROSION OF THE MEMBRANE IS CAUSED WHEN THE DEVICE HAS BEEN STORED IN CONDITIONS OUTSIDE THE RECOMMENDED STORAGE CONDITIONS. THE INVESTIGATION COULD NOT DETERMINE WHAT CONDITIONS THE DEVICE WAS STORED UNDER BETWEEN (B)(6) 2012. 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 PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE STATUS INDICATOR WAS FLASHING RED AND THE DEVICE WAS EMITTING A "DEVICE SERVICE REQUIRED" WARNING. 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
    33392 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE PAD

    Patients

    Seq Age Sex Outcome Treatment
    1