BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3192403 · Received June 18, 2013

    Report

    Report Number
    2031702-2013-00132
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 18, 2013
    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

    THIS MALFUNCTION MDR IS BEING FILED BEYOND THE 30 DAY REPORTING TIMELINE. THE CAREFUSION SERVICE TECHNICIAN HAD REPORTED THE TEST RESULTS BUT IT WAS INADVERTENTLY MISSED WHEN IT WAS TIME TO REPORT THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S ALARM SOUND WAS DISTORTED. 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
    276208 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC. LTV 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI