BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRED VHB20 HEATED HUMIDIFIER

    MDR report key: 18161053 · Received November 16, 2023

    Report

    Report Number
    MW5148255
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Report Date
    November 14, 2023
    Manufacturer
    VINCENT HEALTHCARE PRODUCTS LIMITED
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HUMIDIFIER NOT WORKING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54029 INSPIRED VHB20 HEATED HUMIDIFIER HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VINCENT HEALTHCARE PRODUCTS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown