BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAEGER MEDICAL INC

    MDR report key: 14192254 · Received April 25, 2022

    Report

    Report Number
    14192254
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 14, 2022
    Manufacturer
    DRAEGERWERK AG & CO. KGAA
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN PREPARING A DRAGER VENT TO USE ON CRITICALLY ILL PATIENT, WHEN STARTING UP THE VENT, THE SCREEN FROZE. THE VENT WAS NOT ON ANY PATIENT AT THIS TIME. IT THEN MADE A HIGH PITCHED NOISE WHICH COULD NOT BE TURNED OFF FOR 2 MINUTES. VENT DISCONNECTED FROM WALL AND CONTINUED TO MAKE NOISE, THEN SCREEN FLASHED AND READ "DEVICE FAILED" IN RED BAR ACROSS TOP. IT THEN TURNED OFF. I PULLED VENT OUT OF ROOM AND PUT IT OUT OF SERVICE. MACHINED WAS TAGGED FOR SERVICE. THERE WAS NO PATIENT HARM. AWAITING UPDATE FROM BIOMED ON STATUS AND INVESTIGATION OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200162 DRAEGER MEDICAL INC VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAEGERWERK AG & CO. KGAA EVITA INFINITY V500

    Patients

    Seq Age Sex Outcome Treatment
    1 120 DA Female