BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 6031252 · Received October 14, 2016

    Report

    Report Number
    2112667-2016-02020
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 14, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K092864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAQ(DATA ACQUISITION) BOARD , POWER SUPPLY AND MONITOR TO DAQ BOARD CONNECTOR WERE REPLACED TO FIX THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, THE UNIT SHOWED THE "NO INSPIRATORY FLOW SENSOR" MESSAGE UPON BOOT-UP. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682269 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1