BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6739619 · Received July 25, 2017

    Report

    Report Number
    3004123209-2017-00792
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    July 17, 2017
    Report Date
    August 24, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 300P DEVICE WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DISPATCH OF THE SAM 300P FROM HEARTSINE TECHNOLOGIES, BELFAST ON 23RD JULY 2013 ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2013 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2016. 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°C WITH A LOW OF -0.9°C RECORDED. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE. DEVICES RETURNED FOR SWITCHING ON AUTOMATICALLY HAVE SYMPTOMS INCLUDING AN EXCESS CURRENT DRAIN AND MULTIPLE MANUAL POWER UPS MAINLY OF TEN MINUTE DURATION. THE CURRENT DRAIN OF THE DEVICE WAS WITHIN SPECIFICATION AND THERE WERE NO MULTIPLE MANUAL POWER UPS OR TEN MINUTE MANUAL POWER UPS RECORDED. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED 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 SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522803 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1