BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5398218 · Received January 29, 2016

    Report

    Report Number
    3004123209-2016-00100
    Event Type
    Malfunction
    Date Received
    January 29, 2016
    Date of Event
    January 22, 2016
    Report Date
    February 23, 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
    EI
    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 SUCCESSFULLY ON (B)(6) 2012 AND PASSED ALL SELF-TESTS UP TO (B)(6) 2014. TEMPERATURES ARE RECORDED DURING THIS TIME BELOW THE RECOMMENDED MINIMUM TEMPERATURE. THE DEVICE FAILED A SELF-TEST DUE TO A LOW BATTERY ON THE (B)(6) 2014 AND REMAINED IN FAULT MODE UNTIL (B)(6) 2016 WHEN AN INCREASE IN VOLTAGE WAS OBSERVED, THE DEVICE WAS POWER CYCLED AND PASSED A SELF-TEST. THE DEVICE RECORDED AN ADDITIONAL 3 MANUAL POWER UPS LATER THAT DAY. THIS MAY SUGGEST THE USER WAS REGULARLY POWER CYCLING THE DEVICE OR THE DEVICE WAS SWITCHING ITSELF ON AND THE USER WAS INTERVENING BY SWITCHING THE DEVICE OFF VIA THE ON/OFF BUTTON. NO FURTHER LOG ENTRIES WERE RECORDED. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THERE WERE NO TEN MINUTE TIME OUTS RECORDED HOWEVER THE ONE MINUTE TIME OUTS WOULD SUGGEST THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY AND THE USER WAS INTERVENING BY TURNING THE DEVICE OFF VIA THE ON/OFF BUTTON. THE MEASUREMENTS TAKEN DURING THE INVESTIGATION WOULD CONFIRM A FAILING MEMBRANE. THE GREEN STATUS LED WAS OBSERVED TO CONSTANTLY LIT DURING THE INVESTIGATION, THIS IS A FURTHER SYMPTOM OF MEMBRANE FAILURE. THE FAULT COULD NOT BE MEASURED WITH A GOOD MEMBRANE INSTALLED. 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. DEVICE GREEN STATUS INDICATOR LIT CONSTANTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56782 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1