BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5387982 · Received January 25, 2016

    Report

    Report Number
    3004123209-2016-00059
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    January 14, 2016
    Report Date
    February 11, 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
    DA
    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). THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 8TH SEPTEMBER 2009 AND PERFORMED TO SPECIFICATION UP TO THE 18TH OCTOBER 2015. DURING THIS TIME AN INCREASE IN VOLTAGE SUGGESTS A FURTHER PAD-PAK WAS INSTALLED. ALSO DURING THIS TIME THE DEVICE RECORDS ONE OCCASION IN WHICH THE TEMPERATURE WAS RECORDED BELOW THE MINIMUM RECOMMENDED STAND-BY TEMPERATURE FOR THE DEVICE OF 0 DEGREES CELSIUS WITH A LOW OF -5.6 DEGREES CELSIUS RECORDED. ON THE 23RD OCTOBER 2015 THE DEVICE RECORDS A MANUAL POWER UP LASTING 6 MINUTES DURATION. THE LAST LOG ENTRY ON THE 25TH OCTOBER 2015 RECORDS A SUCCESSFUL AUTO SELF-TEST. 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. ON THE 23RD OCTOBER 2015 THE DEVICE RECORDS A MANUAL POWER UP LASTING 6 MINUTES DURATION. THIS MAY INDICATE THE USER WAS POWER CYCLING THE DEVICE OR THE BEGINNINGS OF A MEMBRANE FAILURE. 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.

    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

    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
    47743 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1