BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2852618 · Received November 26, 2012

    Report

    Report Number
    3004123209-2012-00513
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    July 18, 2011
    Report Date
    November 21, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SERIES OF EVENTS ON THE DEVICE BETWEEN (B)(6) 2011 INDICATE THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY AND ALERTED THE USER BY EMITTING A MEMORY FULL WARNING. THE PAD DEVICE WAS DISASSEMBLED AND UNDER ROUTINE TESTING THE PROBLEM WAS REVEALED TO BE A FAULTY Q37 TRANSISTOR. 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 ON AUTOMATICALLY AND THE DEVICE WAS EMITTING A "MEMORY FULL" WARNING MESSAGE. 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
    1 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1