BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932794 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00184
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 19, 2010
    Report Date
    January 14, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2009 AND OPERATED SUCCESSFULLY UNTIL A FAILED SELF-TEST ON (B)(6) 2010. ON (B)(6) 2010, THE DEVICE FAILED A SELF TEST BECAUSE OF A LOW BATTERY. THIS WENT UNNOTICED BY THE USER AS THE NEXT EVENT IS (B)(6) 2011. THE DEVICE HAD BEEN IN FAULT MODE FOR 10 MONTHS AND THE BATTERY WAS DEPLETED TO THE POINT WHERE IT ISSUED A DEVICE SERVICE REQUIRED MESSAGE. ALTHOUGH NO FAULT WAS FOUND WITH THE PAD OR PAD-PAK, THE PAD-PAK WAS DEPLETED TO THE POINT IT TRIGGERED THE BATTERY MANAGEMENT SYSTEM IN THE DEVICE. THE BATTERIES CAN BE DEPLETED BY A VARIETY OF CONDITIONS INCLUDING THE STORAGE LOCATION OF THE DEVICE, AGE OF BATTERY PACK, AND LEVEL OF MANUAL INTERVENTION. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED 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 THE STATUS INDICATOR WAS FLASHING AND THE DEVICE WAS EMITTING THE "DEVICE SERVICE REQUIRED" WARNING PROMPT. A DEVICE EMITTING THIS WARNING MESSAGE HAS IDENTIFIED A FAULT WITH THE DEVICE AND IF LEFT UNDETECTED, COULD RESULT IN THE FAILURE OF THE DEVICE TO DELIVER THERAPY, IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33433 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1