BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6823532 · Received August 28, 2017

    Report

    Report Number
    3004123209-2017-00895
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 10, 2017
    Report Date
    October 3, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    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).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). AS THIS IS A PRE-2008 MODEL WHICH ONLY CONTAINS A USER ACCESSIBLE MEMORY LOG, NO INFORMATION CAN BE DETERMINED BETWEEN THE DEVICE PASSED 'OUT QAT' ON (B)(6) 2007 AND UPON RECEIPT AT HEARTSINE. THE INVESTIGATION WAS UNABLE TO REPLICATE, OR FIND ANY CONCLUSIVE EVIDENCE, OF THE REPORTED FAULT.

    Description of Event or Problem · 0

    NO PATIENT INVOLVED. DEVICE OBSERVED SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605843 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1