BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2132549 · Received June 8, 2011

    Report

    Report Number
    2031702-2011-00120
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    April 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD STOPPED "PUSHING" AIR TO THE PT. THE VENTILATOR DISPLAYED THE LOW O2 PRESSURE ALARM BUT THERE WAS NO AUDIBLE ALARM WHEN THE REPORTED PROBLEM OCCURRED. PRIOR TO THE EVENT, THE VENTILATOR HAD ALARMED FOR LOW O2 PRESSURE. THE PT WENT INTO RESPIRATORY ARREST. THE PT WAS MANUALLY VENTILATED DURING THE TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC LTV 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R