BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3881456 · Received May 12, 2014

    Report

    Report Number
    3004123209-2014-00489
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 6, 2014
    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
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE PAD UNIT'S STATUS INDICATOR LIGHT DOES NOT FLASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283369 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1