BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5100378 · Received September 24, 2015

    Report

    Report Number
    3004123209-2015-01253
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    September 22, 2015
    Report Date
    October 14, 2015
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST SUCCESSFULLY INSTALLED BY THE USER IN (B)(6) 2010 AND PERFORMED TO SPECIFICATION UP TO THE 1ST SEPTEMBER 2013. MULTIPLE MANUAL POWER UPS ONE OF 10 MINUTES DURATION WERE OBSERVED IN THE DEVICE MEMORY BETWEEN THE SEPTEMBER 2013 AND THE 24TH SEPTEMBER 2015. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THIS RESULTED IN THE GREEN STATUS LED REMAINING CONSTANTLY LIT, THE EXCESS CURRENT DRAIN AND THE DEVICE SWITCHING ITSELF ON AUTOMATICALLY. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. 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 PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHES ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631697 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1