BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2072070 · Received April 21, 2011

    Report

    Report Number
    2031702-2011-00085
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DELIVERED NO FLOW TO THE PATIENT WITH A CONSTANT LOW PRESSURE ALARM. IT WAS ALSO REPORTED THAT THE VENTILATOR WAS VERY HOT TO THE TOUCH. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR