BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915284 · Received December 19, 2012

    Report

    Report Number
    3004123209-2012-00292
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 29, 2012
    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
    NL
    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) 2012. ON (B)(6) 2012 A NEW PAD-PAK WAS INSTALLED. THE DATA OBTAINED FROM THE DEVICE OR THE INVESTIGATION CONFIRMED NO FAULT WITH THE DEVICE OR ANY COMPONENT IN THE DEVICE. TESTING CONCLUDED THAT DEVICE PERFORMED AS EXPECTED AND THE STATUS INDICATOR WAS FLASHING GREEN AS NORMAL. 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 INVOLVEMENT IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE STATUS INDICATOR WAS ILLUMINATED GREEN AND WAS NOT FLASHING AS NORMAL. 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
    1 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1