BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 4181828 · Received October 10, 2014

    Report

    Report Number
    MW5038600
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 10, 2014
    Manufacturer
    GE MEDICAL
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRIOR TO START OF CASE, GAS MACHINE PASSED ALL OF THE REQUIRED CHECKS. APPROXIMATELY FIVE MINUTES AFTER INDUCTION THE MACHINE BECAME INOPERABLE AND ALARMING INTERNAL SERVICING. PATIENT REMOVED FROM VENTILATOR, GIVEN TIVA AND VENTILATED USING AN AMBU BAG AT 100% OXYGEN, 10L/MIN. PATIENT TAKEN TO ANOTHER OPERATING ROOM TO COMPLETE THE CASE. PATIENT REQUIRED NO ADDITIONAL TREATMENT OR MONITORING. BIOMEDICAL CHECKED MACHINE; UNIT WAS DEPRESSURIZING AND WORKING INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640764 AESPIRE VIEW ANESTHESIA UNITS BSZ GE MEDICAL AESPIRE VIEW

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other