BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICIRCUIT

    MDR report key: 1242863 · Received November 19, 2008

    Report

    Report Number
    9610105-2008-00026
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 24, 2008
    Report Date
    November 19, 2008
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INNER BLUE TUBING OF THE UNICIRCUIT BREATHING CIRCUIT WAS TWISTED. THERE WAS NO REPORTED PT INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICIRCUIT PATIENT CIRCUIT CAI GE HEALTHCARE FINLAND OY M1087990

    Patients

    Seq Age Sex Outcome Treatment
    1