BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200I

    MDR report key: 609397 · Received May 17, 2005

    Report

    Report Number
    609397
    Event Type
    Malfunction
    Date Received
    May 17, 2005
    Date of Event
    February 25, 2005
    Report Date
    May 17, 2005
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE UNIT READ SYSTEM FAILURE, BIO MED CALLED TO CHECK OUT THE UNIT. BIO MED TESTED THE UNIT WITH THE MANUFACTURER TECH SUPPORT. THE UNIT NEEDED TO BE SENT BACK TO COMPANY.RECEIVED THE UNIT BACK ABOUT A MONTH LATER, AND THE MANUFACTURER PUT IN A NEW MAG PUMP DRIVE. UNIT WAS SENT BACK TO THE DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 200I HIGH FLOW NASAL CANNULA BTT VAPOTHERM, INC. 2000I *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY