BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/5 AESPIRE CONFIG

    MDR report key: 6017293 · Received October 11, 2016

    Report

    Report Number
    2112667-2016-01985
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 13, 2016
    Report Date
    October 11, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K000706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SWITCH PRESSURE SENSITIVE 20 PSI WAS REPLACED TO FIX THE REPORTED FAILURE. 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 THAT, A NOISE WAS HEARD FROM THE AREA OF THE FAN AND A MESSAGE APPEARS STATING LOW LEVEL OF DRIVE GAS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668342 S/5 AESPIRE CONFIG ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1