BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6735419 · Received July 24, 2017

    Report

    Report Number
    3004123209-2017-00704
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Date of Event
    July 4, 2017
    Report Date
    September 5, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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).

    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 350P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 350P FROM HEARTSINE TECHNOLOGIES, BELFAST ON (B)(6) 2015. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2015 AND THAT IT HAD PERFORMED ALL SELF-TESTS UP TO AND INCLUDING THE LAST LOG ENTRY ON THE (B)(6) 2017. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR AND DELIVERED A TEST SHOCK WITHOUT FAULT ON (B)(6) 2017 INFORMATION FROM THE MEMORY LOG INDICATES THE SHOCK KEY HAD EITHER BEEN STUCK OR HELD ON DURING A MANUAL POWER CYCLE RESULTING IN THE DEVICE POWERING OFF WITH A FLASHING RED STATUS LED AND A "WARNING DEVICE SERVICE REQUIRED" MESSAGE ALONG WITH A FAILURE CHIRP. AFTER EXTENSIVE TESTING NO FAULT COULD BE MEASURED OR OBSERVED WITH THE SHOCK KEY. THE INVESTIGATION FOUND THE FAULT COULD BE CAUSED BY INADVERTENTLY PRESSING THE SHOCK KEY. IT IS POSSIBLE THAT THIS INCIDENT OCCURRED AS A RESULT OF AN EXTERNAL INFLUENCE, E.G. AN OBJECT SITTING ON TOP OF THE DEVICE CAUSING THE SHOCK BUTTON TO BE DEPRESSED. 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.

    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
    518870 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1