BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 6689266 · Received July 6, 2017

    Report

    Report Number
    3004123209-2017-00634
    Event Type
    Malfunction
    Date Received
    July 6, 2017
    Date of Event
    September 28, 2017
    Report Date
    August 30, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 300P 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 350P FROM HEARTSINE TECHNOLOGIES, BELFAST ON THE 22ND OF MAY 2015. UPON VISUAL INSPECTION OF THE RETURNED DEVICE DISTINCT CORROSION WAS OBSERVED ON THE CONTACT COLLARS SIGNIFICANT CORROSION WAS ALSO OBSERVED AROUND THE POGO-PIN SURROUNDINGS, SCREW HEADS AND ON THE RETURNED PAD-PAK CONTACT COLLARS. THE DEVICE HISTORY AND MEMORY LOGS COULD NOT BE DOWNLOADED. A TEST LID WAS USED TO CONNECT THE PCB TO THE PC IN ORDER TO DOWNLOAD THE HISTORY AND MEMORY LOGS. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2015 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2016. BETWEEN (B)(6) 2016, THE DEVICE RECORDS MULTIPLE MANUAL POWER UPS MAINLY OF TEN MINUTE DURATION. THE PAD-PAK WAS THEN REMOVED. MEASUREMENTS OF THE RETURNED PAD-PAK INDICATED IT WAS DEPLETED BEYOND ANY USE. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR DELIVERED A TEST SHOCK WITHOUT FAULT. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE. UPON VISUAL INSPECTION OF THE MEMBRANE TAIL CORROSION WAS OBSERVED ON MULTIPLE TRACKS. 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). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE WILL NOT POWER ON WITH INSTALLED PAD-PAK EXPIRY 08-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471143 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1