BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6119978 · Received November 22, 2016

    Report

    Report Number
    3004123209-2016-01701
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 25, 2016
    Report Date
    December 19, 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
    GR
    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). ROUTINE TESTING CONFIRMED THAT THE PAD-PAK WAS FIRST WAS INSTALLED BY THE CUSTOMER ON THE (B)(6) 2009. ON THE (B)(6) 2013 THE DEVICE FAILED A WEEKLY AUTO SELF-TEST DUE TO A LOW BATTERY. INVESTIGATION FOUND THE FAULT CAN BE ATTRIBUTED TO POGO-PIN DAMAGE. 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, WHICH IS WHY THE "UNKNOWN" BOX HAS BEEN CHECKED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058 HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773860 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1