BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 1811291 · Received August 11, 2010

    Report

    Report Number
    2031702-2010-00157
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD NO AUDIBLE ALARM. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC LTV 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI