BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6105453 · Received November 16, 2016

    Report

    Report Number
    3004123209-2016-01661
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 19, 2016
    Report Date
    December 20, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(4) 2011 AND PERFORMED TO SPECIFICATION, UP TO THE (B)(4) 2015. MULTIPLE MANUAL POWER UPS MAINLY OF TEN MINUTES' DURATION OBSERVED BETWEEN THE (B)(4) 2015 AND THE LAST LOG ENTRY ON THE (B)(4) 2016. DURING THIS PERIOD INFORMATION FROM THE TECHNICAL LOG SHOWS THE DEVICE HAD ENTERED CPR ADVISOR MODE. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE. THE DEVICE SUCCESSFULLY PASSED AN AUTO SELF-TEST AND WAS MANUALLY POWER CYCLED. DURING THE POWER UP MOST OF THE INSTRUCTIONAL LEDS REMAINED ILLUMINATED. THE DEVICE SHUTDOWN WITH A "WARNING MEMORY FULL" PROMPT AND A FLASHING GREEN STATUS LED. THE DEVICE DELIVERED A TEST SHOCK WITHOUT FAULT AND AN ACCEPTABLE MEASUREMENT WAS RECORDED FOR THE TEST SHOCK. THE DEVICE WAS DISASSEMBLED FOR INVESTIGATION. INVESTIGATION FOUND MEMBRANE FAILURE DUE TO MOISTURE INGRESS.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. PAD UNIT POWERS ON BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757956 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1