BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932553 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00103
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    April 4, 2010
    Report Date
    January 9, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2008 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2010. ON THE (B)(6) 2010 THE DEVICE FAILS A SELF TEST FOR A LOW BATTERY. THE DEVICE FAILS SEVERAL MORE SELF TESTS UP TO (B)(6) 2010. BETWEEN THIS DATE AND (B)(6) 2011 THE PAD-PAK APPEARS TO HAVE BEEN REMOVED OR THE DEVICE WAS LEFT IN FAIL MODE. ON THIS DATE A NEW PAD-PAK WAS INSERTED AND THE DEVICE COMPLETED A SELF TEST. THERE ARE NO INDICATIONS FROM THE DEVICE LOG OF THE DEVICE SWITCHING ITSELF ON. THE ORIGINAL PAD-PAK WAS NOT RETURNED SO NO TESTS COULD BE CARRIED OUT ON THAT. ALTHOUGH NO FAULT WAS FOUND WITH THE PAD OR RETURNED 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 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
    33084 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1