BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5384800 · Received January 22, 2016

    Report

    Report Number
    3004123209-2016-00044
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    January 14, 2016
    Report Date
    February 10, 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
    GM
    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 PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 5TH JUNE 2008 AND PERFORMED TO SPECIFICATION UP TO THE 14TH NOVEMBER 2010. DURING THIS TIME THE PAD-PAK WAS REMOVED AND RE-INSTALLED FOR ONE OCCASION FOR A PERIOD OF APPROXIMATELY 13 DAYS. ON THE 21ST NOVEMBER 2010 THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO A LOW BATTERY. AN ADDITIONAL TWO LOW BATTERY FAILS WERE RECORDED ON THE 22ND NOVEMBER 2010. THE DEVICE WAS STILL IN FAULT MODE ON THE 30TH NOVEMBER 2010 WHEN AN INCREASE IN VOLTAGE SUGGESTS A FURTHER PAD-PAK WAS INSTALLED. ON THE 27TH DECEMBER 2015 THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO A LOW BATTERY. THE DEVICE WAS STILL IN FAULT MODE WHEN AN ADDITIONAL LOW BATTERY FAIL WAS RECORDED ON THE LAST HISTORY LOG ENTRY ON THE 8TH JANUARY 2016. THE DEVICE SOFTWARE WAS UPDATED AFTER THIS DATE FROM VERSION 2.0.2 TO 3.2.0 BUT WAS NOT MANUALLY POWER CYCLED. INVESTIGATION WAS UNABLE TO REPLICATE OR FIND ANY EVIDENCE OF THE REPORTED FAULT. THERE WERE NO TEN MINUTE MANUAL POWER UPS IN THE HISTORY LOG. THE INITIAL PAD-PAK PERFORMED AS EXPECTED FOR APPROXIMATELY 29 MONTHS BEFORE ISSUING A LOW BATTERY WARNING. 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
    44491 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1