BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915228 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00262
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 26, 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 Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN JAN 2010 AND THAT IT HAD PERFORMED TO SPEC UP TO FEB 2011. ON 20TH FEB 2011, THE DEVICE FAILED THE WEEKLY SELF-TEST BECAUSE OF A LOW BATTERY. ON DETECTION OF THIS FAULT THE DEVICE WOULD HAVE SWITCHED TO FAULT MODE AND THE CUSTOMER WOULD HAVE BEEN ALERTED WITH THE STATUS INDICATOR FLASHING RED AND THE DEVICE EMITTING AN AUDIBLE WARNING MESSAGE. THE INFO OBTAINED FROM THE DEVICE SHOWED THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY RESULTING IN MANUAL POWER-UPS OF 10 MINUTES IN DURATION OCCURRING ON (B)(4) 2012 AND CONTINUED UP TO (B)(4) 2012. INVESTIGATION DID NOT CONFIRM A FAULT WITH THE DEVICE OR ANY COMPONENT IN THE DEVICE. THE DEVICE SWITCHING ITSELF ON IS A KNOWN SYMPTOM OF A DAMAGED OR FAULTY MEMBRANE. ALTHOUGH IN THIS EVENT, THERE WAS NO FAULT MEASURED, IT IS PROBABLE THAT DAMAGE HAS BEEN CAUSED TO THE MEMBRANE, WHICH HAS AFFECTED THE DEVICE CAUSING IT TO SWITCH ITSELF ON AUTOMATICALLY. A KNOWN EFFECT OF A DEVICE SWITCHING ITSELF ON AUTOMATICALLY IS THE PREMATURE DEPLETION OF THE PAD PAK. TESTING OF THE RETURNED PAD PAK (LOT 671) CONFIRMED THAT IT HAD NOT BEEN FULLY DEPLETED. INVESTIGATION ALSO DETERMINED THAT WHEN TESTED UNDER LOAD, THE CURRENT FLOW THROUGH THE -VE AND +VE BATTERY TERMINAL POGO PINS WAS REDUCED SUFFICIENTLY ENOUGH TO CAUSE FLUCTUATIONS IN VOLTAGE THAT WOULD HAVE BEEN SUFFICIENT TO TRIGGER THE LOW BATTERY WARNINGS. TESTING CONCLUDED THAT WHILST THE FLUCTUATIONS IN VOLTAGE DID NOT PREVENT OPERATION OF 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. 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