BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 360P AND PAD PAK

    MDR report key: 6840883 · Received September 4, 2017

    Report

    Report Number
    3004123209-2017-00907
    Event Type
    Malfunction
    Date Received
    September 4, 2017
    Date of Event
    August 11, 2017
    Report Date
    October 17, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    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 HISTORY RECORDS FOR THE RETURNED SAM 360P DEVICE WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DISPATCH OF THE SAM 360P FROM HEARTSINE TECHNOLOGIES, BELFAST ON 26TH OF APRIL 2016. ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2016. ON (B)(6) 2016, THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO A LOW BATTERY. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR AND DELIVERED A TEST SHOCK WITHOUT FAULT. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE AND NO VISUAL ABNORMALITIES WERE FOUND WITH THE COMPONENTS ON THE PCB. THE RETURNED PAD-PAK WAS DISASSEMBLED AND THE INVESTIGATION FOUND A SINGLE FAILED CELL. THE RETURNED PAD-PAK DEVICE HISTORY RECORD WAS INVESTIGATED SHOWING IT WAS 1 OF (B)(4) PAD-PAK'S MANUFACTURED UNDER LOT A2296, (B)(4) OF WHICH WERE SENT TO MEDX5 ON THE 26TH OF APRIL 2016. ALL PAD-PAK'S WERE SUBJECTED TO A BATTERY VOLTAGE TEST WITH NO RECORDED FAILS. THIS WOULD THEREFORE INDICATE THE CELL FAILED AFTER DISPATCH FROM HEARTSINE. THE USER WOULD HAVE BEEN ALERTED WITH A "WARNING LOW BATTERY, DEVICE SERVICE REQUIRED" PROMPT AND A FLASHING RED STATUS LED. 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.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE DEPLETED PAD-PAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620951 HEARTSINE SAMARITAN 360P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1