BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P PAD PAK

    MDR report key: 6420716 · Received March 21, 2017

    Report

    Report Number
    3004123209-2017-00233
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Date of Event
    February 23, 2017
    Report Date
    April 7, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058 HEARTSINE TECHNOLOGIES LTD ( MANUFACTURER ) IS SUBMITTING THE REPORT ON TECHNOLOGIES LLC ( IMPORTER BEHALF OF HEARTSINE) 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 (B)(6) 2015. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(6) 2015 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO THE AUTO SELF-TEST ON THE (B)(6) 2016. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE AND UPON INTERNAL INSPECTION CORROSION WAS OBSERVED ON MULTIPLE TRACKS OF THE MEMBRANE TAIL. THE CORROSION OBSERVED OVER THE TRACKS LED TO EXCESS CURRENT DRAIN WHICH MEASURED DURING THE INVESTIGATION. THIS LIKELY LED TO THE PREMATURE DEPLETION OF THE INSTALLED PAD-PAK WHICH WOULD ACCOUNT FOR THE LOW BATTERY FAILS DETAILED IN THE COMPLAINT

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE DEPLETING PAD-PAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202767 HEARTSINE SAMARITAN 300P PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability