BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADU

    MDR report key: 2013550 · Received February 3, 2011

    Report

    Report Number
    9610105-2011-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 6, 2011
    Report Date
    February 3, 2011
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BSZ
    PMA / PMN Number
    K050676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SITE REPORTED A LIGHT ANESTHESIA CASE. THE USER STATED THAT A SEVOFLURANE ANESTHESIA CASSETTE STOPPED WORKING DURING A PROCEDURE. THE CASSETTE WAS SET AT 2.5 LITERS AND IT APPEARED TO BE FLOWING BUT THE PT WOKE UP. NO PT INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADU ANESTHESIA MACHINE BSZ GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1