BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3002181 · Received February 11, 2013

    Report

    Report Number
    3004123209-2012-00892
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 30, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN (B)(6) 2010. INFORMATION OBTAINED FROM THE DEVICE SHOWED THAT BETWEEN (B)(6) 2010 AND 2012 THE DEVICE FAILED THE WEEKLY SELF-TESTS ON FIVE SEPARATE OCCASIONS BECAUSE OF A LOW BATTERY. THERE WAS ALSO EVIDENCE THAT THE DEVICE HAD BEEN LEFT IN FAULT MODE FOR FIVE MONTHS. INVESTIGATION CONFIRMED THAT THE DEVICE FAILED THE WEEKLY SELF-TESTS BECAUSE OF A LOW BATTERY, AND THIS WOULD HAVE BEEN CAUSED BY THE DEVICE BEING STORED OUTSIDE THE STORAGE TEMPERATURE CONDITIONS RECOMMENDED FOR THE DEVICE. INVESTIGATION DID NOT CONFIRM A FAULT WITH THE DEVICE OR ANY COMPONENT IN THE DEVICE. DURING TEST THE SOFTWARE WAS SUCCESSFULLY UPGRADED AND THE FAILURE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED. THE RETURNED PAD-PAK (BATTERY AND ELECTRODES) FROM LOT 698 (USE UNTIL JULY 2013) WERE SIGNIFICANTLY DEPLETED. THIS WOULD BE AS A CONSEQUENCE OF THE DEVICE BEING LEFT IN FAULT MODE FOR FIVE MONTHS BECAUSE THE DEVICE USES MORE BATTERY POWER WHEN IT IS IN FAULT MODE THAN IT USES WHEN IT IS IN STAND-BY MODE. INVESTIGATION DID NOT FIND ANY FAULT WITH THE DEVICE OR ANY COMPONENT IN THE DEVICE. IT IS POSSIBLE THAT FOLLOWING THE SOFTWARE UPGRADE THAT THE END USER DID NOT POWER CYCLE THE DEVICE, WHICH MAY EXPLAIN WHY THE STATUS INDICATOR WAS FLASHING RED. 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 AFTER A SOFTWARE UPGRADE. 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
    60376 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1