BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 3143287 · Received May 23, 2013

    Report

    Report Number
    2031702-2013-00115
    Event Type
    Injury
    Date Received
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS OPERATING FINE INITIALLY, BUT THE PATIENT HAD QUITE A BIT OF LIQUID SECRETIONS. AFTER AWHILE, THE TIDAL VOLUMES WOULD FLUCTUATE BETWEEN 3000 AND 47 WITH AUDIBLE ALARMS. THEY CONTINUED TO FLIP FLOP BACK AND FORTH, SO THE CREW CHANGED THE VENTILATOR CIRCUIT, BUT THE PROBLEM CONTINUED. THEY EVENTUALLY REMOVED THE PATIENT FROM THE VENTILATOR AND MANUALLY VENTILATED WITH A BAG-VALVE DEVICE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230058 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention