BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2852600 · Received November 26, 2012

    Report

    Report Number
    3004123209-2012-00395
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    June 3, 2011
    Report Date
    November 19, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2009 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2010. THERE ARE MULTIPLE SELF-TEST FAILS AFTER THIS DATE WHICH WOULD INDICATE THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. THE PROBLEM WITH THE PAD DEVICE WAS ATTRIBUTED TO A FAULT WITH THE MEMBRANE. THE INITIAL PROBLEM WITH THE DEVICE WENT UNNOTICED BY THE USER AND IT WOULD APPEAR THE DEVICE CONTINUED TO SWITCH ON AUTOMATICALLY WHICH DEPLETED THE PAD-PAK. 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, WHICH IS WHY THE "UNKNOWN" BOX HAS BEEN CHECKED IN THIS REPORT.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT 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