BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA/5 7100 COMPACT CONFIGURATION

    MDR report key: 6021497 · Received October 12, 2016

    Report

    Report Number
    2112667-2016-01994
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 14, 2016
    Report Date
    November 30, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K000706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FLOW SENSOR WAS REPLACED TO FIX THE REPORTED ISSUE. 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

    THE INITIAL MDR STATED THAT THE FLOW SENSOR WAS REPLACED TO FIX THE REPORTED ISSUE. THIS FOLLOW-UP MDR IS BEING SUBMITTED TO CLARIFY THAT THE FLOW SENSOR WAS CLEANED AND THEN REINSTALLED. THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, THE TIDAL VOLUME CANNOT BE MEASURED UPON THE START-UP. THE FLAP OF THE FLOW SENSOR IS OPEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672911 AESTIVA/5 7100 COMPACT CONFIGURATION ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1