BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932521 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00050
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    June 9, 2011
    Report Date
    January 4, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PAD DEVICE WAS TESTED AND THE FAULT WAS CONFIRMED. IT WAS REVEALED THE DEVICE HAD NOT PASSED THE FINAL QUALITY ASSURANCE TEST EVEN THOUGH PAPERWORK INDICATED IT HAD PASSED. THE INVESTIGATION INDICATED THE DEVICE HAD ISSUED A DEVICE SERVICE REQUIRED MESSAGE IN GERMAN BUT THIS HAD BEEN OVERLOOKED BY THE OPERATOR AT THE TEST STATION. THE PROBLEM WITH THE DEVICE WAS CAUSED BY A COMBINATION OF INCOMPLETE TESTING AT THE PRINTED BOARD ASSEMBLY SUPPLIER AND THE FAILURE OF THE HEARTSINE OPERATOR TO REACT TO THE FAILURE MESSAGE AT FINAL TESTING. 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 AND THE DEVICE WAS EMITTING THE "DEVICE SERVICE REQUIRED" WARNING PROMPT. A DEVICE EMITTING THIS WARNING MESSAGE HAS IDENTIFIED A FAULT WITH THE DEVICE AND IF LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEVICE TO DELIVER THERAPY IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33377 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1