BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN SAM 300P AND PAD PAK

    MDR report key: 2852200 · Received November 26, 2012

    Report

    Report Number
    3004123209-2012-00024
    Event Type
    Death
    Date Received
    November 26, 2012
    Date of Event
    October 3, 2010
    Report Date
    October 9, 2010
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT THE DEVICE WAS STORED IN A LOCATION WHERE IT WAS NOT ADEQUATELY PROTECTED FROM THE EFFECTS OF ADVERSE ENVIRONMENTAL CONDITIONS. THE STORAGE CONDITIONS WERE OUTSIDE THE RECOMMENDATIONS DETAILED IN THE USER MANUAL SUPPLIED WITH THE DEVICE. TEMPS BELOW ZERO DEGREES CENTIGRADE WERE RECORDED AT THE TIME OF THE WEEKLY SELF TESTS. SIGNIFICANT LEVELS OF CORROSION WERE FOUND INSIDE THE DEVICE ON THE MEMBRANE TAIL. THE MEMBRANE TAIL CONNECTS THE USER INTERFACE MEMBRANE TO THE PRINTED CIRCUIT BOARD IN THE DEVICE. THE DEVICE WAS FOUND TO HAVE DEVELOPED A FAULT AT LEAST 9 MONTHS BEFORE THE REPORTED INCIDENT, AND THE DEVICE WOULD HAVE INDICATED THE FAULT BY THE RED LED BEING ILLUMINATED AND THE DEVICE EMITTING AN AUDIBLE "BEEP". IT WOULD APPEAR THAT THESE WARNINGS WENT UNNOTICED BY THE USER AND THIS CAUSED THE ORIGINAL PAD-PAK TO BECOME COMPLETELY DEPLETED. THE BUILD UP OF CORROSION ON THE MEMBRANE TAIL CAUSED THE DEVICE TO SWITCH ITSELF OFF IMMEDIATELY AFTER BEING SWITCHED ON. THE PAD PAK (BATTERIES AND ELECTRODES) USED IN THE DEVICE IS FOR SINGLE USE ONLY BUT THE PAD 300P DEFIBRILLATOR IS A MULTI USE DEVICE. IT IS NOT KNOWN IF THIS WAS THE FIRST USE OF THE PAD 300P DEVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS REPORTED TO BE DISPLAYING A FLASHING RED LED WHEN IT WAS PRESENTED AT THE SCENE OF THE EVENT. THE PAD-PAK (BATTERIES AND ELECTRODES COMBINED) WAS CHANGED AND THE STATUS INDICATOR CHANGED TO A FLASHING GREEN LED INDICATING THAT THE DEVICE WAS READY FOR USE. HOWEVER WHEN THE DEVICE WAS SWITCHED ON BY THE USER, IT ISSUED A FEW SPEECH PROMPTS AND THEN SWITCHED ITSELF OFF. THE USER WAS UNABLE TO SWITCH THE DEVICE ON AGAIN. UNFORTUNATELY, THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSINE SAMARITAN SAM 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD SAM 300P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death