BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWMETER

    MDR report key: 8677498 · Received June 7, 2019

    Report

    Report Number
    9611500-2019-00168
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    May 23, 2019
    Report Date
    August 13, 2019
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS CARRIED OUT BASED ON THE PROVIDED FLOWMETER. IT WAS FOUND THAT THE MATERIAL OF THE PRESSURE DOME IS TORN IN THE REGION OF THE THREAD WITH WHICH THE DOME IS SCREWED INTO THE BASE BODY OF THE FLOWMETER. THE CLEANING WIPES MICROBAC TISSUES USED ACCORDING TO THE CUSTOMER WORK ON THE BASIS OF QUATERNARY COMPOUNDS, WHICH ARE NOT RECOMMENDED BY DRÄGER AND ARE NOT COMPATIBLE WITH THE MATERIAL OF THE PRESSURE DOME (POLYCARBONATE) WHICH CAN LEAD TO STRESS CRACKS. ACCORDINGLY, THE REPORTED RUPTURE OF THE PRESSURE DOME CAN MOST LIKELY BE ATTRIBUTED TO STRESS CRACKS CAUSED BY THE USE OF INCOMPATIBLE CHEMICALS. STRESS CRACKING FINALLY RESULTING IN BURSTING IS NOT A SUDDEN EVENT, BUT A SLOW-MOVING PROCESS THAT CAN BE DETECTED IN TIME WITH REGULAR INSPECTION. THEREFORE THE IFU CONTAINS A WARNING THAT THE USER HAS TO CHECK THE PRESSURE DOME FOR CRACKS BEFORE USE. FURTHERMORE, THE PRESSURE DOME SHOULD BE CHECKED AT LEAST ONCE A YEAR BY TRAINED SPECIALIST PERSONNEL; IN DOING SO, THE PRESSURE DOME MUST BE UNSCREWED FROM THE FLOWMETER IN ORDER TO ALSO CHECK THE THREAD FOR ABNORMALITIES AND CRACKS.

    Description of Event or Problem · 0

    PLEASE REFER TO THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ON-GOING. THE RESULTS WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE FLOWMETER THE PRESSURE DOME EXPLODED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473659 FLOWMETER FLOWMETER, GAS BXY DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1