BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 7100

    MDR report key: 6051937 · Received October 24, 2016

    Report

    Report Number
    2112667-2016-02088
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 24, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K000706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT WAS CAUSED BY A LEAK. SEVERAL COMPONENTS OF THE BREATHING SYSTEM WERE REPLACED TO CORRECT THIS LEAK, AND THE UNIT WAS RETURNED TO SERVICE. NO REPORT OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT PRESSURE MODE OF MECHANICAL VENTILATION WAS NOT WORKING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702303 AESTIVA 7100 ANETHESIA MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1