BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5580359 · Received April 15, 2016

    Report

    Report Number
    3004123209-2016-00458
    Event Type
    Malfunction
    Date Received
    April 15, 2016
    Date of Event
    April 5, 2016
    Report Date
    May 14, 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 HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 10TH NOVEMBER 2011 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO THE 31ST JANUARY 2016. THROUGHOUT THIS PERIOD THE DEVICE RECORDS MULTIPLE OCCASIONS IN WHICH THE TEMPERATURE WAS RECORDED BELOW THE MINIMUM RECOMMENDED STAND-BY TEMPERATURE OF 0 DEGREES CELSIUS WITH A LOW OF -2.3 DEGREES CELSIUS. MULTIPLE MANUAL POWER UPS MAINLY OF TEN MINUTES DURATION WERE OBSERVED BETWEEN THE 5TH FEBRUARY 2016 AND THE LAST LOG ENTRY ON THE 15TH APRIL 2016. DURING THIS TIME THE PAD-PAK BECAME DEPLETED. INVESTIGATION FOUND REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE DUE TO CORROSION. THE CORROSION INDICATES THE DEVICE HAD BEEN STORED IN ADVERSE CONDITIONS. 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 SWITCHES ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237977 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1