BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915249 · Received December 19, 2012

    Report

    Report Number
    3004123209-2012-00829
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    February 27, 2011
    Report Date
    December 14, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2008 AND OPERATED SUCCESSFULLY UNTIL A FAILED SELF TEST ON (B)(6) 2011. THIS WAS REPORTED BUT THE DEVICE WAS NOT RETURNED. THE USER THEN MANUALLY SWITCHED ON THE DEVICE THREE TIMES IN (B)(6) 2011. THE DEVICE FAILED A SELF TEST ON (B)(6) 2011 DUE TO A LOW BATTERY. ALTHOUGH NO FAULT WAS FOUND WITH THE PAD OR 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 IN THE DEVICE HAD BEEN IN USE FOR 2 YEARS AND 9 MONTHS. THE DEVICE FAILED ITS SECOND TEST ON (B)(6) 2011 AND IT HAD BEEN IS USE FOR 3 YEARS AND 3 MONTHS. BOTH PAD-PAKS HAD AN EXPIRY DATE OF SEPT 2011. 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 THE STATUS INDICATOR WAS FLASHING AND THE DEVICE WAS EMITTING THE "DEVICE SERVICE REQUIRED" WARNING PROMPT. A DEVICE EMITTING THIS WARNING MESSAGE HAS IDENTIFIED A FAULT WITH THE DEVICE AND IF LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEVICE TO DELIVER THERAPY 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