BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2892127 · Received December 23, 2012

    Report

    Report Number
    2892127
    Event Type
    Malfunction
    Date Received
    December 23, 2012
    Date of Event
    October 24, 2012
    Report Date
    December 26, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GE REFERENCE NUMBER M1148290, LOT NUMBER 123004 HAD AN OBSTRUCTION DUE TO MANUFACTURING QUALITY CONTROL ISSUE. THE ANESTHESIOLOGIST'S VIGILANCE AND TROUBLESHOOTING AVERTED A NEGATIVE OUTCOME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BREATHING CIRCUIT, ANESTHESIA CAH GE HEALTHCARE * 123004

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR