BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5038114 · Received August 28, 2015

    Report

    Report Number
    3004123209-2015-00978
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 12, 2015
    Report Date
    November 24, 2015
    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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 16TH JULY 2009 AND PERFORMED TO SPECIFICATION UP TO THE 9TH SEPTEMBER 2012. MULTIPLE MANUAL POWER UPS MAINLY OF 10 MINUTES DURATION WERE RECORDED BETWEEN THE 14TH SEPTEMBER 2012 AND THE FINAL HISTORY LOG ENTRY ON THE 15TH FEBRUARY 2014. THE PAD-PAK BECAME DEPLETED WITH A FRESH PAD-PAK SUBSEQUENTLY BEING INSTALLED. THE PAD-PAK ALSO APPEARED TO BE TAKEN IN AND OUT OF THE DEVICE DURING THIS PERIOD DUE TO THE GAPS IN THE LOG. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE / DAMAGED POGO PINS. THE 10 MINUTE TIME OUTS WOULD SUGGEST A FAILING MEMBRANE. UPON VISUAL INSPECTION OF THE RETURNED DEVICE ALL FOUR POGO PINS WERE OBSERVED TO BE SHEARED OFF AND BOTH LOCATOR PINS WERE BROKEN OFF. THIS WOULD SUGGEST THE DAMAGE OCCURRED DURING INCORRECT INSERTION OF THE PAD-PAK. IT CAN BE CONCLUDED THAT THIS HAPPENED AFTER THE FINAL HISTORY LGO ENTRY ON THE 15TH FEBRUARY 2014 AS THE DEVICE POWERED ON AT THAT TIME AND DAMAGE TO THE POGO PINS WOULD HAVE PREVENTED THE DEVICE FROM RECORDING FURTHER SELF-TESTS. 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 · 1

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. PAD UNIT HAS BROKEN POGO PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571157 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1