BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6746319 · Received July 27, 2017

    Report

    Report Number
    3004123209-2017-00752
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    July 10, 2017
    Report Date
    September 21, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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).

    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 WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 300P FROM HEARTSINE TECHNOLOGIES, BELFAST ON THE 28TH MAY 2013. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2013 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2017. DURING THE INVESTIGATION, THE STATUS LED FAILED TO FLASH GREEN WITH A PAD-PAK INSTALLED. THIS WOULD CONFIRM THE REPORTED FAULT. THE FAULT COULD NOT BE REPLICATED WITH A KNOWN GOOD MEMBRANE FITTED. THIS WOULD INDICATE A FAILURE WITHIN THE ORIGINAL MEMBRANE. THE FAILURE OF THE GREEN STATUS LED TO FLASH WAS CAUSED BY A POOR SILVER PASTE CONNECTION BETWEEN THE LED AND THE MEMBRANE TRACKS.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. STATUS INDICATOR LIGHT DOES NOT FLASH, RED OR GREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529312 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1