BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM

    MDR report key: 6841840 · Received September 5, 2017

    Report

    Report Number
    6841840
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    November 26, 2016
    Report Date
    August 16, 2017
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VAPOTHERM APPLIED AND WHERE THE CANNULA FOR THE NOSE AND THE TUBING CONNECT, REPEATEDLY COMES APART. HAPPENED ON 2 DIFFERENT PREMATURE BABIES. THE ISSUE IS RELATED TO THE BOND BETWEEN THE TUBING OF THE CANNULA AND THE PIECE WHERE THE PRONGS ARE LOCATED. WE ONLY HAVE EXPERIENCED THE ISSUE WITH PREMATURE SIZE CANNULAS (REF #85-MN1100AEA) FOR USE WITH THE VAPOTHERM PRECISION FLOW DEVICE. THE LOT NUMBERS IDENTIFIED WERE 083115 AND 020915. ALL SUPPLIES WITH THOSE LOT NUMBERS WERE REMOVED AND REPLACED BY THE VENDOR. VENDOR ALSO TOOK TWO EXAMPLES OF THE CANNULAS THAT HAD ACTUALLY FAILED. NO HARM TO EITHER BABY AND HAS NOT HAPPENED SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621671 VAPOTHERM HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VAPOTHERM, INC. 083115

    Patients

    Seq Age Sex Outcome Treatment
    1