BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE

    MDR report key: 3921628 · Received May 29, 2014

    Report

    Report Number
    2112667-2014-00083
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    DATEX-OHMEDA INC.
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HOSP REPORTED A PT WOKE UP DURING THE CASE. THE CLINICIAN REPORTEDLY SEDATED THE PT, REPLACED THE ANESTHESIA MACHINE, AND CONTINUED THE CASE. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316253 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1