BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 5090486 · Received September 21, 2015

    Report

    Report Number
    3004123209-2015-01240
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 18, 2015
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. PAD UNIT HAS SELF-ACTIVATED WITHOUT ENDUSER INPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622204 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1