BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3002159 · Received February 11, 2013

    Report

    Report Number
    3004123209-2013-00396
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    March 29, 2012
    Report Date
    January 21, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE THREE RECORDED EVENTS IN THE HISTORY OF THE RETURNED PAD DEVICE. ALL THESE OCCUR ON (B)(6) 2012. ALL EVENTS PRIOR TO THIS DATE HAVE BEEN ERASED. THE DEVICE WAS DISASSEMBLED FOR INVESTIGATION AND TESTING REVEALED A FAULT WITH R247 COMPONENT IN THE ON/OFF CIRCUITRY. WITHOUT A FULL HISTORY OF THE DEVICE THE REPORTED PROBLEM WAS ATTRIBUTED TO A FAULT WITH R247 COMPONENT. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE IT WAS SWITCHING ITSELF ON AUTOMATICALLY. A DEVICE SWITCHING ITSELF ON AUTOMATICALLY, IF LEFT UNDETECTED COULD RESULT IN THE BATTERY BECOMING DEPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60404 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1