BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4232473 · Received October 17, 2014

    Report

    Report Number
    3004123209-2014-01352
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 13, 2014
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE DEVICE MALFUNCTIONED BECAUSE THE DEVICE WAS EMITTING A HUMMING NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662002 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1