BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2982829 · Received January 28, 2013

    Report

    Report Number
    3004123209-2012-00279
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    November 7, 2012
    Report Date
    January 4, 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 Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN (B)(4) 2010 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(4) 2012. INVESTIGATION CONFIRMED THE DEVICE FAILED TO UPGRADE TO SOFTWARE VERSION 3.2.0 USING THE HEARTSINE SAMARITAN PAD UNIVERSAL UPGRADER. TESTING ALSO CONFIRMED THAT THE DEVICE WAS CAPABLE OF DELIVERING THERAPY IN THIS FAULT MODE. THIS DEVICE WAS REPLACED WITHIN 24 HRS. 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 INVOLVEMENT IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE FAILED TO UPGRADE THE SOFTWARE ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37110 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1