BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2845029 · Received October 24, 2012

    Report

    Report Number
    2031702-2012-00268
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FIELD SERVICE TECHNICIAN THAT THE VENTILATOR'S TURBINE WOULD NOT START. FOUND PINCHED TURBINE WIRES BETWEEN REAR WELDMENT AND TURBINE MANIFOLD SPACER BRACKET. NO INSULATION DAMAGE VISIBLE. THE PT'S MOTHER STATED THE VENTILATOR DID NOT CYCLE FOR 30 SECONDS 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 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR