BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMIDIFIER

    MDR report key: 17661635 · Received August 30, 2023

    Report

    Report Number
    MW5145102
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Report Date
    August 29, 2023
    Manufacturer
    VINCENT HEALTHCARE PRODUCTS LIMITED
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    "DOES NOT WORK PROPERLY." 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
    1182983 HUMIDIFIER HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VINCENT HEALTHCARE PRODUCTS LIMITED VHB20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown