BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE 7100

    MDR report key: 6054853 · Received October 25, 2016

    Report

    Report Number
    2112667-2016-02099
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 27, 2016
    Report Date
    October 25, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K000706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. THE BAG/VENT SWITCH WAS ORDERED FOR REPLACEMENT. 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 A FAILURE OF THE BAG/VENT SWITCH TO OPERATE AS EXPECTED. THERE IS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707331 AESPIRE 7100 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1