BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2892332 · Received November 30, 2012

    Report

    Report Number
    3004123209-2012-00523
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    July 29, 2011
    Report Date
    November 21, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO OBTAINED FROM THIS DEVICE INDICATED THAT THE DEVICE WAS FIRST INSTALLED ON (B)(6) 2009 AND SUCCESSFULLY CARRIED OUT WEEKLY SELF-TESTS UNTIL (B)(6) 2010. AFTER THIS DATE, THE DEVICE BEGAN TO EMIT A LOW BATTERY WARNING AND FAILING SELF-TESTS. THE USER WAS ALERTED TO A PROBLEM BY THE RED STATUS INDICATOR FLASHING. THE RETURNED PAD DEVICE FAILED SELF-TESTS DUE TO A LOW BATTERY. THE BATTERY CAN BECOME DEPLETED IF STORED IN A LOCATION WHERE IT IS EXPOSED TO ADVERSE ENVIRONMENTAL CONDITIONS. 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, WHICH IS WHY THE "UNKNOWN" BOX HAS BEEN CHECKED IN THIS REPORT.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE DEVICE WOULD NOT POWER-ON. 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