BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915209 · Received December 19, 2012

    Report

    Report Number
    3004123209-2012-00853
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    March 1, 2011
    Report Date
    December 17, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS ONE RECORDED EVENT ON THE RETURNED PAD DEVICE OCCURRING ON (B)(6) 2011. THE GREEN STATUS LED WAS NOT FLASHING. THE DEVICE DID NOT SWITCH ITSELF ON, BUT WHEN SWITCHED ON MANUALLY WAS NOT ABLE TO BE MANUALLY SWITCHED OFF. THE DEVICE WAS DISASSEMBLED FOR INSPECTION AND IT WAS DISCOVERED A COMPONENT Q55 TRANSISTOR HAD BECOME PARTIALLY DETACHED FROM THE PRINTED CIRCUIT BOARD. THIS WOULD HAVE AFFECTED THE ON/OFF CIRCUITRY CONFIRMING THE FAULT. IT IS LIKELY THE COMPONENT BECAME DETACHED THROUGH EXCESSIVE PRESSURE APPLIED TO THE ON/OFF SWITCH AND THIS DEVELOPED OVER TIME. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED 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