BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932539 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00055
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 16, 2010
    Report Date
    January 4, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER ATTEMPTED TO INSTALL THE PAD DEVICE ON (B)(6) 2010. SOME OF THE INFORMATION RECORDED ON THIS DAY IS NONSENSICAL AND THE HISTORY LOG CONTINUES TO RECORD AUTOMATIC AND MANUAL SELF TESTS UP TO (B)(6) 2011. NONSENSICAL DATA AND MULTIPLE EVENTS WOULD INDICATE A POOR CONNECTION BETWEEN THE PAD AND THE PAD-PAK. THE POGO-PINS WERE TESTED AND FOUND THAT UNDER LOAD THE CURRENT FLOW THROUGH THE POGO-PINS DROPPED TO ZERO WHEN THE PAD-PAK WAS AGITATED. THIS WOULD CAUSE THE GREEN LED TO DIM AND THE RED LED TO FLASH INDICATING A FAULT. 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 DEVICE WORKS FOR A PERIOD OF TIME AND THEN THE GREEN LED SLOWLY DIMS AND RED LED STARTS TO FLASH. A DEVICE IN THIS FAULT MODE, IF LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEICE TO PERFORM AS INTENDED IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33382 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1