BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5456249 · Received February 24, 2016

    Report

    Report Number
    3004123209-2016-00246
    Event Type
    Malfunction
    Date Received
    February 24, 2016
    Date of Event
    February 18, 2016
    Report Date
    April 13, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 PAD-PAK WAS FIRST INSTALLED ON THE 25TH NOVEMBER 2013 AND PERFORMED TO SPECIFICATION UP TO THE 6TH DECEMBER 2015. THE DEVICE FAILED MULTIPLE SELF-TESTS DUE TO A LOW BATTERY BETWEEN THE 13TH DECEMBER 2015 AND THE 21ST FEBRUARY 2016. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE AND FAILED TO POWER ON, NO STATUS LED WAS VISIBLE. THIS WOULD CONFIRM THE REPORTED FAULT. AN ACCEPTABLE SHOCK WAS DELIVERED DURING THE TESTING. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO A SHORT CIRCUIT BETWEEN THE GREEN AND RED STATUS LEDS DUE TO OVER APPLICATION OF SILVER PASTE. THIS RESULTED IN LEAKAGE CURRENT TO THE BEEPER AND WOULD HAVE INCREASE THE CURRENT DRAIN OF THE DEVICE AND LIKELY LED TO THE PREMATURE DEPLETION OF THE RETURNED PAD-PAK. IT IS CONCLUDED THAT THE SHORT CIRCUIT WAS INTERMITTENT IN NATURE AS THE STATUS LEDS ARE TESTED DURING FINAL TEST. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO STATUS INDICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113535 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1