BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLOW DISPOSABLE PATIENT CIRCUIT

    MDR report key: 1982528 · Received February 4, 2011

    Report

    Report Number
    1125759-2010-00004
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    June 23, 2010
    Report Date
    February 1, 2011
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    MEDWATCH REPORT NUMBER (B)(4) RECEIVED (B)(6) 2010. A HOSPITAL RESPIRATORY THERAPIST WAS SETTING UP A PRECISION FLOW HUMIDIFICATION UNIT WHEN WATER CAME OUT OF THE DISPOSABLE PT CIRCUIT (DPC). THE DPC WAS REPLACED AND THE SET UP WAS SUCCESSFULLY COMPLETED. VAPOTHERM FOUND THE DPC AIR VENTING MEMBRANE TO BE DAMAGED (CUT). THE CAUSE OF THE DAMAGE WAS ATTRIBUTED TO HANDLING DURING MFG. CORRECTIONS TO THE MFG SYSTEM HAVE BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FLOW DISPOSABLE PATIENT CIRCUIT DISPOSABLE PATIENT CIRCUIT BTT VAPOTHERM, INC. PF-DPC-LOW 10043011307

    Patients

    Seq Age Sex Outcome Treatment
    1