BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 5086380 · Received September 17, 2015

    Report

    Report Number
    2031702-2015-00215
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 11, 2015
    Report Date
    September 17, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. INTERNAL INSPECTION OF THE TURBINE REVEALED A WHITE POWDERY SUBSTANCE. THE TURBINE WAS SEIZED DUE TO APPARENT WATER CONTAMINATION AND CORROSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DID NOT PASS THE LEAK TEST. THE VENTILATOR JUST CLICKS WITH THE BREATH RATE OF 12 AND DOES NOT BLOW AIR. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614648 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 950

    Patients

    Seq Age Sex Outcome Treatment
    1