BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5510106 · Received March 18, 2016

    Report

    Report Number
    3004123209-2016-00308
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Date of Event
    March 7, 2016
    Report Date
    May 12, 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
    MD, US
    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 ON THE 18TH NOVEMBER 2010 AND THAT IT HAD PERFORMED ALL WEEKLY AUTO SELF-TESTS, ALONGSIDE TWO MANUAL POWER ONS, UP TO THE 19TH JULY 2015. DURING THAT 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 -5 DEGREES CELSIUS RECORDED. MANUAL POWER UPS OF TEN MINUTES WERE RECORDED BETWEEN THE 21ST JULY 2015 AND THE LAST LOG ENTRY ON THE 8TH MARCH 2016. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE TIME OUTS AND THE MEASUREMENTS TAKEN WOULD SUGGEST A FAILING MEMBRANE. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. 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. UNIT POWERS ON BY ITSELF WITHOUT MANUAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167789 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1