BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW SENSOR

    MDR report key: 550244 · Received October 13, 2004

    Report

    Report Number
    550244
    Event Type
    Malfunction
    Date Received
    October 13, 2004
    Date of Event
    October 12, 2004
    Report Date
    October 13, 2004
    Manufacturer
    DATEX OHMEDA
    Product Code
    BXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL INCIDENT REPORT STATES: THAT WHEN THE VENTILATOR WAS TURNED ON, A MESSAGE APPEARED STATING "VENT FAIL- INSPIRATORY FLOW SENSOR AND REPLACE INSPIRATORY FLOW SENSOR...TO GET VENTILATION TO WORK, FLIP SWITCH TO BAG MODE AND SWITCH BACK." AS REPORTED TO BIOMED, THE VENTILATOR WAS NOT TESTED BEFORE THE CASE AND THE FLOW SENSORS HAD BEEN REPLACED THE NIGHT BEFORE WITH THE NEWER, METALLIC TUBE STYLE, SENSORS.THE FLOW SENSOR UNIT WAS REPLACED AND VENTILATION BEGAN NORMALLY AFTER THAT.THE FLOW SENSOR ASSEMBLY WAS BROUGHT TO THE BIOMED DEPT FOR MORE TESTING AND INSTALLED IN THE BACKUP MACHINE. IMMEDIATELY UPON TURNING ON THE MACHINE, A "INSP FLOW SENSOR FAIL" MESSAGE APPEARED. THE SENSOR ASSEMBLY WAS REMOVED AND RE-CALIBRATED WITH SAME RESULT. ERROR MESSAGES DUPLICATE THE ONES REPORTED IN THE IR, INCIDENT REPORT. THERE WAS NO VISIBLE DAMAGE OR MOISTURE. STAFF RESPONDED CORRECTLY BY REPLACING THE FLOW SENSOR ASSEMBLY AND FILING AN INCIDENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW SENSOR AUTOCLAVABLE TYPE BXY DATEX OHMEDA 1503-3244-000 AE0730

    Patients

    Seq Age Sex Outcome Treatment
    1 *