BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 4374372 · Received December 18, 2014

    Report

    Report Number
    2021710-2014-00105
    Event Type
    Injury
    Date Received
    December 18, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 13, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE DEVICE/COMPONENT WAS RETURNED TO CAREFUSION'S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE IDENTIFIED ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO FAILED REGULATOR. AT THIS TIME, CAREFUSION WILL TRACK AND TREND THIS REPORTED ISSUE AND INTERNALLY INVESTIGATE THE SITUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAREFUSION FIELD SVC TECH EVALUATED THE VENTILATOR AND REPLACED THE TURBINE TO FIX THE REPORTED VENTILATOR INOPERATIVE ISSUE. THE TECH ALSO REPLACED THE BLENDER TO CORRECT A LEAK FOUND DURING TESTING. THE VENTILATOR MEETS PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WAS ALARMING "TRANSDUCER FAULT" WHILE ON A PT AND THEY CLAIM THE THERAPIST WAS WITH THE PT WHEN THE PROBLEM OCCURRED. THE VENTILATOR WAS REMOVED FROM THE PT AND THE PT WAS PLACED ON ANOTHER VENTILATOR. NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834698 CAREFUSION CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention