BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTILATOR

    MDR report key: 3840202 · Received May 22, 2014

    Report

    Report Number
    MW5036328
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 21, 2014
    Manufacturer
    GE HEALTHCARE
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT BECAME DISCONNECTED FROM THE VENTILATOR AND THE VENTILATOR ALARMED AS IT SHOULD. THE VENT ALARM DID NOT TRIGGER THE CALL LIGHT TO GO OFF ABOVE THE DOOR OUTSIDE OF THE PATIENT'S ROOM NOR DID IT PRODUCE AN AUDIBLE ALARM AT THE TELEMETRY MONITORING STATION. VENTILATOR ALARMING ON (B)(6) 2014 APPROXIMATELY 1300. PATIENT FOUND DISCONNECTED FROM VENT AND SATS IN THE 90'S. VENTILATOR ALARM DID NOT TRIP THE CALL LIGHT TO ALARM AT THE MONITOR STATION. GE CAME OUT TO CHECK THE VENTILATOR. VENTILATOR WAS REPORTED TO BE FUNCTIONING PROPERLY. THE CORD THAT PLUGS INTO THE VENTILATOR AND INTO WALL/CALL LIGHT SYSTEM IS FELT TO HAVE NOT BEEN FIRMLY PLUGGED IN. DIRECTOR OF RT HAS ADDED FOR STAFF TO CHECK THE CORD CONNECTION ON THEIR VENT ROUNDS. LONESTAR CALLED TO COME OUT AND DO A CHECK OF THE CALL LIGHT SYSTEM IN THE WALL FOR ROOM 407. PATIENT WAS MOVED TO ROOM 400 WHEN THIS HAPPENED ON (B)(6) 2014 AND NEW VENT/CORD WAS PLACED ON THE PATIENT. VENT WAS TAGGED OUT UNTIL COULD BE CHECKED BY GE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304376 VENTILATOR VENTILATOR CBK GE HEALTHCARE 1505-9000-000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention