BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGSTROM CARESTATION

    MDR report key: 3893465 · Received June 18, 2014

    Report

    Report Number
    3893465
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION
    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

    PATIENT'S VENTILATOR STOPPED GIVING BREATHS SUDDENTLY WITH ONE ALARM THAT WAS SILENCED; THEN THERE WERE NO FURTHER ALARMS WHILE IT SLOWLY COUNTED DOWN FROM SET RATE OF 24 TO 20, 16,10,9 THEN A FLAT LINE WITH NO BREATHS BEING GIVEN. DESPITE CHECKING ALL TUBING BEING CONNECTED AND VENT PLUGGED IN, NO BREATHS WERE GIVEN DESPITE VENTILATOR SCREEN STILL LIT. NO FURTHER ALARMS DESPITE NO FUNCTIONING BY THE VENTILATOR. PERFORMED SUPER USER CALIBRATIONS AND UNIT PASSES ALL TESTING. VENTILATOR WAS REMOVED FROM SERVICE. THE RN WAS IN THE PATIENT'S ROOM AT THE TIME, AND WAS ABLE TO BAG THE PATIENT. PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359320 ENGSTROM CARESTATION VENTILATOR, CONTINUOUS, FACILITY USE CBK GE MEDICAL SYSTEMS INFORMATION RT *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR