BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6438449 · Received March 28, 2017

    Report

    Report Number
    3004123209-2017-00325
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 16, 2017
    Report Date
    July 25, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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, BELFAST ON THE (B)(6) 2011. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(6) 2012 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO THE AUTO SELF-TEST ON THE (B)(6) 2016. UPON VISUAL INSPECTION CORROSION WAS OBSERVED ON THE CONTACT COLLARS AND THE MEMBRANE APPEARED SUNKEN WITH MULTIPLE SCRATCH MARKS. CORROSION WAS ALSO OBSERVED ON BOTH THE SHOCK KEY AND ON/OFF BUTTON WHICH RESULTED IN THE DEVICE FAILING TO POWER ON. THROUGHOUT THE HISTORY LOG THE DEVICE RECORDS MULTIPLE OCCASIONS IN WHICH THE TEMPERATURE WAS RECORDED BELOW THE MINIMUM RECOMMENDED STAND-BY TEMPERATURE OF 0°C WITH A LOW OF -8.8°C RECORDED. THIS COMBINED WITH CORROSION OBSERVED ON THE CONTACT COLLARS AND THE DISCOLOURATION OF THE MEMBRANE ALONGSIDE MULTIPLE SCRATCH MARKS OBSERVED WOULD INDICATE ADVERSE STORAGE CONDITIONS.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT .ON/OFF BUTTON DOES NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221779 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1