BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5537419 · Received March 31, 2016

    Report

    Report Number
    3004123209-2016-00397
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 21, 2016
    Report Date
    May 24, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 SUCCESSFULLY INSTALLED ON THE 15TH APRIL 2011 AND IT HAD PASSED SELF-TESTS UP TO THE 31ST JANUARY 2016. ON THE 7TH FEBRUARY 2016 AND THE 6TH MARCH 2016 THE DEVICE RECORDS A POWER UP CONTAINING NONSENSICAL DATA. MANUAL POWER UPS OF LESS THAN ONE MINUTE DURATION WERE RECORDED ON THE LAST LOG ENTRY ON THE 21ST MARCH 2016. THIS MAY SUGGEST THE USER WAS REGULARLY POWER CYCLING THE DEVICE OR THE DEVICE WAS SWITCHING ITSELF ON AND THE USER WAS INTERVENING BY POWERING OFF THE DEVICE VIA THE ON/OFF BUTTON. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE GREEN STATUS LED REMAINED CONSTANTLY LIT AND COMBINED WITH THE EXCESS CURRENT DRAIN AND MEASUREMENTS TAKEN CONFIRM A FAILING MEMBRANE. SLIGHT VOLTAGE FLUCTUATION WAS OBSERVED OVER THE POGO PINS HOWEVER THIS HAD NO IMPACT ON THE ABILITY OF THE DEVICE TO DELIVER THERAPY. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. UNIT POWERS ON BY ITSELF WITHOUT MANUAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194651 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1