BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932505 · Received January 23, 2013

    Report

    Report Number
    3004123209-2012-00469
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 4, 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
    GM
    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 THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2011. THE INFORMATION OBTAINED FROM THE DEVICE SHOWED THAT ON (B)(6) 2011, THE DEVICE FAILED A WEEKLY SELF-TEST BECAUSE OF A LOW BATTERY. THE DEVICE WOULD HAVE SWITCHED TO FAULT MODE AND THE CUSTOMER WOULD HAVE BEEN ALERTED WITH THE STATUS INDICATOR FLASHING RED AND THE DEVICE WOULD HAVE ISSUED AN AUDIBLE WARNING MESSAGE. ON (B)(6) 2011, THE DEVICE FAILED A MANUAL TEST BECAUSE OF A LOW BATTERY. THE DEVICE REMAINED IN FAULT MODE UP TO(B)(6) 2012. ON THE (B)(6) 2012 AND (B)(6) 2012, THE DEVICE FAILED FURTHER MANUAL TESTS BECAUSE OF A LOW BATTERY. THE DEVICE REMAINED IN FAULT MODE UNTIL (B)(6) 2012 WHEN A NEW PAD-PAK WAS INSTALLED. THERE WAS NO EVIDENCE FROM THE DATA TO SHOW THAT THERE WAS AN ATTEMPT MADE TO UPGRADE THIS DEVICE AS REPORTED BY THE CUSTOMER. INVESTIGATION DID NOT CONFIRM THERE TO BE A FAULT WITH THE DEVICE OR ANY COMPONENT IN THE DEVICE. THE RETURNED PAD PAK (LOT 399) WAS BEYOND ITS USE UNTIL DATE OF 05/2012. THE DEVICE SOFTWARE WAS SUCCESSFULLY UPGRADED FROM VERSION 2.0.2 TO 3.2.0. 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 DEVICE WOULD NOT POWER ON AFTER UPGRADING THE SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33370 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE PAD

    Patients

    Seq Age Sex Outcome Treatment
    1