BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932771 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00191
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    July 3, 2011
    Report Date
    January 16, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2007 AND OPERATED SUCCESSFULLY UNTIL A FAILED SELF TEST ON (B)(6) 2011 DUE TO A LOW BATTERY. THE DEVICE FAILED ITS WEEKLY SELF A FURTHER 4 TIMES BETWEEN (B)(6) 2011, ALL FOR LOW BATTERIES. AFTER THIS DATE, THERE ARE MULTIPLE EVENTS ON THE SAME DAY, WHICH WOULD INDICATE THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. NO FAULT WAS FOUND WITH THE RETURNED PAD DEVICE. THE PAD-PAK USED IN THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE PAD-PAK WAS LIKELY TO BE CLOSE, IF NOT PAST, ITS EXPIRY DATE. THE LOW BATTERY WARNINGS WERE DELIVERED BECAUSE 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 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
    33096 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1