BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICIRCUIT

    MDR report key: 1171951 · Received September 19, 2008

    Report

    Report Number
    9610105-2008-00021
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 19, 2008
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BZO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT LOT NUMBER COULD NOT BE DETERMINED. THE LOT NUMBER IS ONE OF FOUR POSSIBILITIES: LOT NUMBER: 081638. PRODUCTION DATE: APR 17, 2008. LOT NUMBER: 075009. PRODUCTION DATE: DEC 12, 2007. LOT NUMBER: 081220. PRODUCTION DATE: MAR 19, 2008. LOT NUMBER: 080131. PRODUCTION DATE: JAN 4, 2008.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY NOTED PATIENT HAD AN INCREASED CO2 READING DURING A CASE. INSPECTION OF THE BREATHING CIRCUIT REPORTEDLY REVEALED THAT THE BLUE INNER CIRCUIT WAS NO LONGER ATTACHED TO THE OUTER CIRCUIT. THERE WAS NO REPORTED PATIENT 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 BZO GE HEALTHCARE FINLAND OY 8570075

    Patients

    Seq Age Sex Outcome Treatment
    1