BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUCAS

    MDR report key: 8015280 · Received October 29, 2018

    Report

    Report Number
    8015280
    Event Type
    Death
    Date Received
    October 29, 2018
    Date of Event
    October 12, 2018
    Report Date
    October 26, 2018
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    DRM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT FOUND DOWN AT HOME WITH AN UNKNOWN DOWN TIME. BROUGHT TO THE ED BY EMS CODING. PATIENT WAS CALLED AS A STEMI BY THE ED AND BROUGHT TO THE CATH LAB. SHE ARRIVED INTUBATED AND ON A VENTILATOR. PATIENT WAS PREPPED AND DRAPED IN THE USUAL FASHION. A HEART CATHETERIZATION WAS PERFORMED ON THE PATIENT. THE CORONARY ARTERIES DID NOT SHOW ANY BLOCKAGES. WHEN CROSSING THE AORTIC VALVE THE PATIENT LOST HER PULSE AND BLOOD PRESSURE. CPR AND ACLS WERE STARTED. A CODE BLUE WAS CALLED. CCU NURSES, RESPIRATORY, AND CCM MD'S ARRIVED TO ASSIST. MD CALLED TIME OF DEATH. INJURIES FOUND ON AUTOPSY DUE TO USE OF LUCAS CHEST COMPRESSION DEVICE. THE LEFT SUBCLAVIAN ARTERY HAD RUPTURED PLAQUE. THERE WERE MULTIPLE TEARS IN THE PERICARDIAL SAC WITH PERIAORTIC SOFT TISSUE HEMORRHAGE AND HEMORRHAGE INTO BOTH PULMONARY HILA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853355 LUCAS COMPRESSOR, CARDIAC, EXTERNAL DRM PHYSIO-CONTROL

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Death