BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 7900

    MDR report key: 5142134 · Received October 9, 2015

    Report

    Report Number
    2112667-2015-00166
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 16, 2015
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K023366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT. A LOW-PRESSURE LEAK WAS NOTED AROUND THE O-RING THAT SEALS THE OXYGEN FLOWMETER. THE SEAL WAS CLEANED AND THE LEAK WAS RESOLVED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE FIO2 (FRACTION INSPIRED OXYGEN) WAS LOWER THAN EXPECTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671951 AESTIVA 7900 ANESTHESIA MACHINE CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1