BEUDAMED
    FDA Adverse Event Death Summary report: N

    E500 VENTILATOR

    MDR report key: 2237139 · Received September 2, 2011

    Report

    Report Number
    2023050-2011-00046
    Event Type
    Death
    Date Received
    September 2, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 5, 2011
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K061094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE PT DIED AT THE HOSPITAL WHILE ON THE VENTILATOR. IT WAS DETERMINED THAT THE DEATH OF THE PT WAS DUE TO HER/HIS PREEXISTING MEDICAL CONDITION, NOT DUE TO THE FUNCTIONALITY OF THE VENTILATOR. THE VENTILATOR GAVE PROPER ALARMS DURING VENTILATION. AFTER THE REPORTED EVENT, A TECHNICIAN FROM THE DISTRIBUTOR WENT TO THE HOSPITAL AND EVALUATED THE VENTILATOR. THE TECH IDENTIFIED A LARGE AMOUNT OF CONTAMINATION ON THE FLOW SENSOR SCREEN AT THE PT EXHALATION SIDE. THIS CONTAMINATION WAS FROM THE PT'S EXHALED BREATH (GAS). THE VENTILATOR WAS BROUGHT BACK TO THE DISTRIBUTOR FOR A FURTHER INSPECTION. PER THE DISTRIBUTOR, THE CONTAMINATED/DIRTY FLOW SENSOR SCREEN WAS DUE TO LACK OF USER MAINTENANCE AT THE HOSPITAL AND NOT A DEVICE MALFUNCTION. NOTE: IF THE CONTAMINATED FLOW SENSOR WERE TO RECUR, IT WOULD NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E500 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death