BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 6917144 · Received October 5, 2017

    Report

    Report Number
    3004123209-2017-01142
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 15, 2017
    Report Date
    October 25, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P16008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 350P DEVICE WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DISPATCH OF THE SAM 300P FROM HEARTSINE TECHNOLOGIES, BELFAST ON 20TH APRIL 2015. ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2015 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2017. BETWEEN THE 5TH AUGUST 2017 AND THE LAST LOG ENTRY ON (B)(6) 2017, THE DEVICE BEGAN TO PERFORM MULTIPLE POWER UPS OF MAINLY TEN MINUTES DURATION. DURING THIS TIME, INFORMATION FROM THE TECHNICAL LOG RECORDS THE DEVICE ENTERING CPR ASSIST MODE. AFTER FURTHER INVESTIGATION, IT WAS FOUND THAT THE MEMBRANE OF THE DEVICE HAD FAILED DUE TO CORROSION CAUSED BY MOISTURE INGRESS. CORROSION WAS OBSERVED ON THE DEVICE ON/OFF BUTTON OF THE MEMBRANE. THIS LIKELY RESULTED IN THE DEVICE SWITCHING ON AUTOMATICALLY AND WOULD ACCOUNT FOR THE TEN-MINUTE MANUAL POWER UPS RECORDED IN THE HISTORY LOG.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    NO PATIENT INVOLVED. DEVICE SWITCHES ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698773 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1