BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5090467 · Received September 21, 2015

    Report

    Report Number
    3004123209-2015-01213
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 15, 2015
    Report Date
    October 5, 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
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY LOG FOR THE DEVICE SHOWED THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY IN NOVEMBER 2009 AND PERFORMED TO SPECIFICATION, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO THE (B)(6) 2014. THE DEVICE FAILED MULTIPLE SELF-TESTS DUE TO A LOW BATTERY BETWEEN (B)(6) 2014. AN INCREASE IN VOLTAGE SUGGESTS LATER ON THIS DATE SUGGESTS A FURTHER PAD-PAK WAS INSTALLED. THE DEVICE PERFORMED AS EXPECTED UP TO THE (B)(6) 2014. THE DEVICE RECORDS MULTIPLE MANUAL POWER ONS OF 10 MINUTES DURATION BETWEEN THE(B)(6) 2014 AND THE LAST LOG ENTRY ON THE (B)(6) 2015. THE PAD-PAK BECAME DEPLETED DURING THIS TIME. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE TIME OUTS WOULD SUGGEST A FAILING MEMBRANE. 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, WHICH IS WHY THE "UNKNOWN" BOX HAS BEEN CHECKED.

    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
    623996 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1