BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECLIPSE OXYGEN SYSTEM

    MDR report key: 803777 · Received January 10, 2007

    Report

    Report Number
    2030505-2007-00001
    Event Type
    Death
    Date Received
    January 10, 2007
    Report Date
    January 5, 2007
    Manufacturer
    SEQUAL TECHNOLOGIES, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K013931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN DISCUSSION WITH THE PATIENT'S ATTORNEY, THE PATIENT WAS A MALE WHO WAS BEING RELEASED FROM THE HOSPITAL DUE TO PNEUMONIA AND HEART RELATED CONDITIONS. HE WAS DISCHARGED FROM THE HOSPITAL IN 12/06 WITH AN ECLIPSE UNIT. HIS WIFE HAD PICKED HIM UP AT THE HOSPITAL AND ON THEIR WAY HOME HAD STOPPED AT A PHARMACY. THIS WAS AN ESTIMATED 15 MINUTES BETWEEN THE HOSPITAL AND PHARMACY. ON THE WAY HOME FROM THE PHARMACY, THE ECLIPSE STARTED ALARMING. ONCE AT THE HOUSE, THE UNIT WAS STILL ALARMING. SHE CALLED 911. THE PATIENT SUBSEQUENTLY DIED A SHORT TIME LATER. THE PATIENT'S ATTORNEY INDICATED THAT THIS IS ONLY AN EXPLORATORY INQUIRY AT THE TIME TO DETERMINE IF THERE WAS A MALFUNCTION WITH THE PRODUCT OR NOT. THE UNIT IS CURRENTLY BEING HELD BY THE PATIENT'S ATTORNEY. THE ATTORNEY HAS AGREED TO ALLOW SEQUAL TECHNOLOGIES INC AND CV MEDICAL SOLUTIONS TO EVALUATE THE UNIT ON A DATE THAT IS MUTUALLY AGREEABLE TO ALL PARTIES. ARRANGEMENTS FOR THIS DATE ARE STILL BEING WORKED OUT, HOWEVER, IT IS EXPECTED TO BE LATE JANUARY / EARLY FEBRUARY 2007. AN AMENDED REPORT WILL BE SUBMITTED AFTER EXAMINATION OF THE PRODUCT.

    Description of Event or Problem · 1

    SEQUAL RECEIVED A POSSIBLE LITIGATION CLAIM BEING INVESTIGATED REGARDING CIRCUMSTANCES SURROUNDING A PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE OXYGEN SYSTEM ECLIPSE OXYGEN SYSTEM BYJ SEQUAL TECHNOLOGIES, INC. 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death