BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 6075687 · Received November 3, 2016

    Report

    Report Number
    2112667-2016-02159
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 7, 2016
    Report Date
    November 3, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K092864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A GEHC SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND WAS NOT ABLE TO CONFIRM THE REPORTED COMPLAINT, HOWEVER A CHECK OF THE ERROR LOGS CONFIRMED THE FAILURE HAD OCCURRED. THE FLOW CONTROL VALVE, DRIVE GAS CHECK VALVE, AND DATA ACQUISITION BOARD WERE REPLACED. THE UNIT WAS RETURNED TO SERVICE. (B)(4). THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT ALARMED AND LOST THE ABILITY TO MECHANICALLY VENTILATE DURING PREUSE CHECKOUT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727288 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1