BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915273 · Received December 19, 2012

    Report

    Report Number
    3004123209-2012-00441
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 12, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN (B)(6) 2008 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2012. THE INFO OBTAINED FROM THE DEVICE, SHOWED THE DEVICE FAILED THE WEEKLY SELF-TEST BECAUSE OF A LOW BATTERY ON (B)(6) 2010, AND (B)(6) 2012. ON EACH OCCASION, THE DEVICE WOULD HAVE SWITCHED TO FAULT MODE AND THE CUSTOMER WOULD HAVE BEEN ALERTED BY THE STATUS INDICATOR FLASHING RED AND THE DEVICE EMITTING AN AUDIBLE WARNING MESSAGE. THE EVIDENCE FROM THE DEVICE INDICATES THAT FOLLOWING THE INSTALLMENT OF A NEW PAD-PAK, THERE WERE SIGNIFICANT DROPS IN VOLTAGE AT THE NEXT WEEKLY SELF-TEST. THE PATTERN OF VOLTAGE DROPS IS INDICATIVE OF SWAPPING OUT A NEW PAD-PAK WITH A PARTIALLY DEPLETED PAD-PAK. THERE WAS NO EVIDENCE FROM THE DEVICE TO CONFIRM THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. INVESTIGATION DID NOT CONFIRM A FAULT WITH THE DEVICE OR ANY COMPONENT IN THE DEVICE. 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
    1 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1