BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2892503 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00199
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 2, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN 06/2010 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(4) 2012. 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 07/24/2012 AND CONTINUED CONSISTENTLY UP TO (B)(4) 2012. INVESTIGATION CONFIRMED THERE TO BE A FAULT WITH THE DEVICE MEMBRANE. THE BREAKDOWN OF THE MEMBRANE CAUSED THE GREEN STATUS LED TO REMAIN ILLUMINATED INSTEAD OF FLASHING AND CAUSED EXCESSIVE CURRENT DRAIN OF THE DEVICE, WHICH RESULTED IN THE EARLY DEPLETION OF PAD PAK (LOT 761). PAD PAK (LOT 761) HAD A USE UNTIL DATE OF (B)(4) 2013 BUT BECAME DEPLETED ON (B)(4) 2012. 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 INVOLVEMENT IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE STATUS INDICATOR STAYED ILLUMINATED INSTEAD OF FLASHING. 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