BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915215 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00743
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2009
    Report Date
    December 6, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2008 AND OPERATED SUCCESSFULLY UNTIL A FAILED SELF TEST ON (B)(6) 2009. THE ABSENCE OF ANY OTHER EVENTS WOULD INDICATE THE FAULT WENT UNNOTICED AND THIS WOULD CAUSE THE PAD-PAK TO DRAIN AT A QUICKER RATE. THE USER WOULD HAVE BEEN ALERTED TO THE PROBLEM BY A FLASHING RED LED AND AN AUDIBLE BEEP. THERE IS ALSO EVIDENCE THAT THE DEVICE WAS STORED IN A LOCATION WHERE IT WAS EXPOSED TO ADVERSE ENVIRONMENTAL CONDITIONS. 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 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 PATIENT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE STATUS INDICATOR WAS FLASHING RED AND THE DEVICE WOULD NOT POWER OFF. A DEVICE IN THIS FAULT MODE, IF LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEVICE TO PERFORM AS INTENDED IF REQUIRED.

    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