BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4792648 · Received May 15, 2015

    Report

    Report Number
    3004123209-2015-00525
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    May 5, 2015
    Report Date
    June 30, 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
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN JULY 2009 AND PERFORMED TO SPECIFICATION UP TO THE 13TH DECEMBER 2009. BETWEEN THE 20TH DECEMBER 2009 AND 4TH MARCH 2015 THE DEVICE FAILED MULTIPLE SELF-TESTS DUE TO A LOW BATTERY. TEMPERATURES RECORDED DURING THIS TIME WERE BELOW THE RECOMMENDED OPERATING TEMPERATURE RANGE FOR THIS DEVICE. IT IS REASONABLE TO CONCLUDE THAT DEVICES RETURNED FOR THE REPORTED FAULT MAY BE ATTRIBUTED TO MEMBRANE FAILURE DUE TO ADVERSE STORAGE CONDITIONS. THERE WERE NO TEN MINUTE TIME OUTS RECORDED HOWEVER THE REPORTED FAULT WAS WITNESSED DURING THE INVESTIGATION. THE GREEN STATUS LED WAS OBSERVED TO BE CONSTANTLY LIT BETWEEN FLASHES DURING THE INVESTIGATION, THIS IS A FURTHER SYMPTOM OF MEMBRANE FAILURE. THE REPORTED FAULT AND THE GREEN STATUS LED FAILURE COULD NOT BE REPLICATED WITH A KNOWN GOOD MEMBRANE INSTALLED. 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. THIS DEVICE WAS MALFUNCTIONED, AS THE DEVICE SWITCHES ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317973 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1