BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE

    MDR report key: 10411427 · Received August 14, 2020

    Report

    Report Number
    2112667-2020-02207
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 17, 2020
    Report Date
    August 14, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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. DATE OF DEVICE MANUFACTURE IS BETWEEN MAY 26, 2005 AND JUNE 25, 2005. THE MONTH OF MANUFACTURE WAS UNAVAILABLE AT TIME OF MDR FILING. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE FLOW SENSORS WERE REPLACED TO RESOLVE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A MALFUNCTION RESULTING IN MORE THAN 20% OVER DELIVERY OF TIDAL VOLUME. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873364 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1