BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915285 · Received December 19, 2012

    Report

    Report Number
    3004123209-2012-00290
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 29, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN (B)(6) 2010 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2012. THE INFO OBTAINED FROM THE DEVICE SHOWED THAT THE DEVICE FAILED THE WEEKLY SELF-TEST ON (B)(6) 2012 BECAUSE OF A LOW BATTERY. THE TEMPERATURE RECORDED AT THE TIME OF THIS SELF-TEST WAS OUTSIDE THE LOWER LIMIT OF THE RECOMMEND STORAGE TEMPERATURE FOR THIS DEVICE (0 DEGREES CELSIUS TO 50 DEGREE CELSIUS/32F TO 122F). INVESTIGATION CONFIRMED THERE TO BE A FAULT WITH THE +VE TERMINAL POGO PIN AND -VE TERMINAL POGO PIN. WHEN TESTED UNDER LOAD THE CURRENT FLOW THROUGH THE PINS WAS REDUCED AND CAUSED FLUCTUATIONS IN THE VOLTAGE. THE FLUCTUATIONS WERE SUFFICIENT FOR THE DEVICE TO IDENTIFY A LOW BATTERY AND TRIGGER THE LOW BATTERY WARNING. TESTING OF THE RETURNED DEVICE AND BATTERY (PAD-PAK, LOT 648) WERE TESTED AND IT WAS FOUND THAT BOTH WERE CAPABLE OF OPERATING TO SPECIFICATION. WHILST THE NOTED FLUCTUATIONS WERE SIGNIFICANT ENOUGH TO TRIGGER THE LOW BATTERY THEY DID NOT PREVENT THE 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 THE STATUS INDICATOR WAS FLASHING RED AND THE DEVICE WAS EMITTING A LOW BATTERY WARNING. A DEVICE IN THIS FAULT MODE, IF LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEVICE TO PERFORM AS INTENDED 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