BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 4435805 · Received December 19, 2014

    Report

    Report Number
    3004123209-2014-02006
    Event Type
    Death
    Date Received
    December 19, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 17, 2014
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. PAD UNIT HAS LOW BATTERY WARNING ON POWERING DOWN OF UNIT AT THE END OF USAGE OF AN SCA EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838078 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death