BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2860028 · Received October 31, 2012

    Report

    Report Number
    2031702-2012-00277
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 31, 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
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CABLE HAD AN EXPOSED WIRE. IT IS RECOMMENDED THAT THE TURBINE BE REPLACED AS A PRECAUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRANSPORT, THE VENTILATOR SEIZED UP (NOT BLOWING AIR AND NUMBERS FROZE ON THE DISPLAY) WITH NO AUDIBLE ALARM WHILE CONNECTED TO THE PT. 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 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1