BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2873502 · Received November 15, 2012

    Report

    Report Number
    2031702-2012-00291
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S TURBINE DID NOT ROTATE WITH AN AUDIBLE ALARM. IT IS UNKNOWN IF THE VENTILATOR WAS CONNECTED TO A PATIENT WHEN THE REPORTED PROBLEM OCCURRED.

    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 NI