BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE 7100

    MDR report key: 5810277 · Received July 20, 2016

    Report

    Report Number
    2112667-2016-01374
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    June 20, 2016
    Report Date
    July 20, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K000706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. THE GE HEALTHCARE SERVICE REPRESENTATIVE REPLACED THE PRESSURE RELIEF VALVE, AND THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE GE HEALTHCARE SERVICE REPRESENTATIVE REPORTED THAT THE UNIT HAD A LARGE LEAK IN THE ADVANCED BREATHING SYSTEM DURING A DIAGNOSTIC CHECK OF THE UNIT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464045 AESPIRE 7100 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1