BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 900

    MDR report key: 2141321 · Received June 1, 2011

    Report

    Report Number
    2031702-2011-00115
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Report Date
    June 1, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS ORIGINALLY SENT TO THE FIELD SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. DURING SERVICE, THE TURBINE DID NOT ENGAGE WITH AN AUDIBLE ALARM WHEN THE VENTILATOR WAS POWERED ON. THE VENTILATOR WAS NOT CONNECTED TO A PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA