BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN PAD300P AND PAD-PAK

    MDR report key: 1671714 · Received April 29, 2010

    Report

    Report Number
    3004123209-2010-00002
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    March 26, 2010
    Report Date
    April 19, 2010
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INSPECTION AND TESTING BY HEARTSINE TECHNOLOGIES, NO FAULT WAS FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS FOUND TO HAVE CORRECTLY ANALYZED THE PT AND ADVISED A SHOCK ON TWO OCCASIONS. EVALUATION SUMMARY: CONCLUSION: THE DEVICE PERFORMED AS EXPECTED. THE PAD-PAK BATTERY PACK WAS DEPLETED TO THE POINT WHERE THE BATTERY MANAGEMENT SYSTEM WAS TRIGGERED. HOWEVER, THE DEVICE WAS STILL CAPABLE OF DELIVERING THERAPY IF IT HAD BEEN REQUIRED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT "THE AED PADS WERE ATTACHED TO THE PT - IT ANALYSED AND RECOMMENDED A SHOCK - WE CLEARED THE PT, AND PUSHED THE SHOCK BUTTON. THE DEVICE THEN STATED THAT THE BATTERY WAS LOW AND IT WAS UNABLE TO DELIVER THE SHOCK, THEN POWERED DOWN AND ALL LIGHTS TURNED OFF." THE PT LATER DIED AND THE CAUSE OF DEATH WAS CONFIRMED AS A C1 SPINE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSINE SAMARITAN PAD300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD PAD300P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death