BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 5996398 · Received October 4, 2016

    Report

    Report Number
    5996398
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    July 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENT READING LOW MV. RT HAD JUST MADE ROUNDS AND CHARTED LOW EXHALED TV. EXHALED TV GOING DOWN ON LAST FEW ASSESSMENTS. PATIENT POH 7.16. PCO2 71. VENT CHANGED OUT AND PATIENT'S ABGS IMPROVED. VENT TAKEN BY RT TO BE REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648213 VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAEGER MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR