BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5090473 · Received September 21, 2015

    Report

    Report Number
    3004123209-2015-01228
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 16, 2015
    Report Date
    December 17, 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
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD-PAK WAS FIRST INSTALLED ON THE 7TH OCTOBER 2010. THE DEVICE RECORDED MULTIPLE MANUAL POWER ONS, MAINLY OF LESS THAN ONE MINUTE DURATION, UP TO THE 15TH NOVEMBER 2010. DURING THIS PERIOD A MANUAL POWER UP OF 13 MINUTES DURATION WAS RECORDED ON THE 22ND OCTOBER 2010 SUGGESTING THE DEVICE DETECTED AN IN-RANGE IMPEDANCE. THE PAD-PAK WAS REMOVED AFTER THIS AND THEN INSTALLED AGAIN ON THE 26TH OCTOBER 2010 WITH THE DEVICE PASSING AN AUTO SELF-TEST. ON THE 6TH JUNE 2014 THE DEVICE FAILED A SELF-TEST DURING A MANUAL POWER CYCLE DUE TO A LOW BATTERY WITH A SIGNIFICANT VOLTAGE DROP OF APPROXIMATELY 6V. MULTIPLE MANUAL POWER UPS OF TEN MINUTES DURATION WERE RECORDED BETWEEN THE 7TH JANUARY 2015 AND THE FINAL HISTORY LOG ENTRY ON THE 15TH SEPTEMBER 2015. DURING THIS TIME THE PAD-PAK BECAME DEPLETED AND WAS REPLACED. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE OUTS WOULD SUGGEST A FAILING MEMBRANE. THE FAULT WAS WITNESSED DURING THE INVESTIGATION. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. THE 6V FLUCTUATIONS MAY SUGGEST THE USER WAS SWITCHING BETWEEN THE DEPLETED AND NEW PAD-PAK OR AN INTERMITTENT FAILURE OF THE BATTERY TERMINAL POGO-PINS GIVEN THE SLIGHT FLUCTUATION NOTICED DURING STRESS TESTING. 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. DEVICE SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622335 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1