BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5522629 · Received March 24, 2016

    Report

    Report Number
    3004123209-2016-00276
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    February 29, 2016
    Report Date
    March 23, 2016
    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
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058 HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). 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. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE HOWEVER THE MULTIPLE MANUAL POWER UPS MAY INDICATE THE USER WAS REGULARLY POWER CYCLING THE DEVICE OR THE BEGINNINGS OF MEMBRANE FAILURE. 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 · 0

    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
    180170 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1