BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6481638 · Received April 11, 2017

    Report

    Report Number
    3004123209-2017-00387
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 29, 2017
    Report Date
    June 23, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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). 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, (B)(4) ON THE 1ST FEBRUARY 2011. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(6) 2011 AND THAT IT HAD PERFORMED ALL SELF-TESTS UP TO AND INCLUDING THE LAST LOG ENTRY ON THE (B)(6) 2017. DURING THIS PERIOD INFORMATION SHOWS THE PAD-PAK WAS REMOVED ON TWO OCCASIONS FOR PERIODS OF UP TO APPROXIMATELY 4 MONTHS. ALSO DURING THIS TIME THE DEVICE RECORDS MULTIPLE OCCASIONS IN WHICH THE TEMPERATURE WAS RECORDED BELOW THE RECOMMENDED STAND-BY TEMPERATURE FOR THE DEVICE OF 0°C WITH A LOW OF -1.4°C RECORDED. THE INVESTIGATION FOUND THE FAULT CAN BE ATTRIBUTED TO AN INTERMITTENT FAILURE OF A MICROPROCESSOR. THROUGHOUT THE HISTORY LOG THE DEVICE RECORDS MULTIPLE OCCASIONS IN WHICH THE TEMPERATURE IS RECORDED OUTSIDE THE RECOMMENDED OPERATING RANGE OF 0-50°C WITH A LOW OF -1.4°C RECORDED. THIS WOULD INDICATE THE DEVICE WAS STORED IN ADVERSE CONDITIONS. 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. RED STATUS INDICATOR AND BEEPING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265464 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention