BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5433260 · Received February 12, 2016

    Report

    Report Number
    3004123209-2016-00201
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    February 9, 2016
    Report Date
    March 1, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 SUCCESSFULLY INSTALLED ON THE 13TH JULY 2012 AND PERFORMED TO SPECIFICATION, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO THE 15TH NOVEMBER 2015. MULTIPLE MANUAL POWER UPS MAINLY OF TEN MINUTES DURATION WERE OBSERVED IN THE DEVICE MEMORY BETWEEN NOVEMBER 2015 AND THE 8TH FEBRUARY 2016. THE PAD-PAK BECAME DEPLETED DURING THIS TIME AND A FURTHER PAD-PAK WAS INSTALLED. NO FURTHER LOG ENTRIES WERE RECORDED PRIOR TO RECEIPT AT HEARTSINE. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE, THE DEVICE WAS POWER CYCLED HOWEVER MOST THE INSTRUCTION LEDS REMAINED ILLUMINATED. THE DEVICE GAVE A MEMORY FULL WARNING AND POWERED ON AUTOMATICALLY, THIS INDICATES A FAULT. A TEST PAD-PAK WAS INSTALLED, THE DEVICE WAS POWER CYCLED HOWEVER FAILED TO SHUT DOWN USING THE ON/OFF BUTTON. THIS INDICATES A FAULT. THE DEVICE WAS DISASSEMBLED FOR INVESTIGATION. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE DUE TO CORROSION. THIS RESULTED IN MANUAL POWER UPS OF TEN MINUTES DURATION BEING RECORDED. THIS CONFIRMS THE REPORTED FAULT.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHES ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91682 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1