BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4853146 · Received June 3, 2015

    Report

    Report Number
    3004123209-2015-00485
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    April 21, 2015
    Report Date
    June 1, 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
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DETAILED IN THIS REPORT WAS RETURNED TO HEARTSINE TECHNOLOGIES AS PART OF THE FSCA/RECALL Z-0124-2013 WITH NO ALLEGATION OF ANY FAULT WITH THE DEVICE. IT WAS THEREFORE INITIALLY ASSESSED AS NON-REPORTABLE HOWEVER SUBSEQUENT ENGINEERING INVESTIGATION REVEALED A FAULT WITH THE DEVICE WHICH WOULD CLASSIFY THE EVENT AS REPORTABLE. INVESTIGATION FOUND THE FAULT MAY BE ATTRIBUTED TO MEMBRANE FAILURE. THERE WERE A NUMBER OF MANUAL POWER UPS THROUGHOUT THE HISTORY LOG WHICH MAY SUGGEST A FAILING MEMBRANE.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THIS DEVICE WAS RETURNED TO HEARTSINE TECHNOLOGIES AS PART OF THE CURRENT FSCA/RECALL, FDA REFERENCE Z-0124-2013. NO FAULT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360851 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1