BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6724279 · Received July 19, 2017

    Report

    Report Number
    3004123209-2017-00702
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    June 29, 2017
    Report Date
    July 27, 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
    UK
    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).

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. CANNOT DOWNLOAD MEMORY, RATTLE INSIDE.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE DEVICE HISTORY RECORDS FOR THE SAM PAD 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DISPATCH OF THE DEVICES FROM HEARTSINE TECHNOLOGIES, (B)(4) ON (B)(4) 2008. ON RECEIPT THE DEVICE COULD NOT BE CONNECTED TO THE PC VIA THE USB AND THE HISTORY AND MEMORY LOGS COULD NOT BE DOWNLOADED. A DISTINCT RATTLE COULD ALSO BE HEARD. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE. UPON VISUAL INSPECTION, THE RED WIRE OF THE USB DATA CABLE WAS DISCONNECTED FROM THE USB CONTACT COLLAR. THE SCREW WAS NOT SECURED AND THIS WAS OBSERVED TO BE LOOSE WITHIN THE DEVICE. AFTER REATTACHING THE WIRE THE DEVICE HISTORY AND MEMORY LOGS COULD BE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(4) 2008 AND THAT IT HAD PERFORMED TO SPECIFICATION, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO THE (B)(4) 2010. ON THE (B)(4) 2010 THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO LOW BATTERY. ON THE (B)(4) 2010, INFORMATION FROM THE HISTORY LOG SHOWS AN INCREASE IN VOLTAGE WHICH SUGGESTS A FURTHER PAD-PAK WAS INSTALLED. THE DEVICE SUCCESSFULLY PERFORMED ALL SELF-TESTS BETWEEN THE (B)(4) 2010 AND THE LAST LOG ENTRY ON THE (B)(4) 2017. DURING THE ABOVE PERIOD THE DEVICE RECORDS 75 MANUAL POWER ONS, MAINLY UNDER ONE MINUTE DURATION BETWEEN THE (B)(4) 2010 AND THE (B)(4) 2017. MOST THESE OCCUR DURING THE WORKING WEEK AND MAY INDICATE THE USER WAS REGULARLY POWER CYCLING THE DEVICE. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR USING THE RETURNED PAD-PAK ON THE (B)(4) 2017 AND DELIVERED A TEST SHOCK WITHOUT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507339 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1