BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3002111 · Received February 11, 2013

    Report

    Report Number
    3004123209-2013-00481
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    October 2, 2011
    Report Date
    January 21, 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 PAD DEVICE WAS INSTALLED ON (B)(6) 2010 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2011. ON (B)(6) 2011, MULTIPLE MANUAL POWER UPS OCCURRED AS WELL AS A FAILED SELF TEST FOR A LOW BATTERY. THE PAD-PAK WAS REMOVED ON THIS DATE AND RE-INSERTED ON (B)(6) 2011 AND PASSED A SELF TEST AFTER WHICH THE PAD-PAK WAS REMOVED. AGAIN ON (B)(6) 2011, A PAD-PAK WAS INSTALLED AND PASSED AN AUTO SELF TEST BEFORE THE PAD-PAK WAS REMOVED AGAIN. THIS PATTERN OF INSERTION AND REMOVAL OCCURRED A FURTHER 3 TIMES. BETWEEN (B)(6) 2012 THERE WERE MULTIPLE EVENTS OF 10 MINUTES DURATION WHICH WOULD INDICATE THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO A FAULT IN THE MEMBRANE. 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.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE IT WAS SWITCHING ITSELF ON AUTOMATICALLY. 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
    60123 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1