BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBREEZE 25STA

    MDR report key: 16253925 · Received January 26, 2023

    Report

    Report Number
    MW5114527
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 19, 2023
    Report Date
    January 24, 2023
    Manufacturer
    RESVENT MEDICAL TECHNOLOGY CO., LTD
    Product Code
    QOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RESVENT IBREEZE BPAP BREATHING THERAPY DEVICE INTERMITTENTLY AND WITHOUT WARNING INTERRUPTS BREATHING CYCLE DURING INHALATION STAGE. REPORTED TO SUPPLIER (B)(4) ON (B)(6) 2023 AT 1220P. ADVISED IN THAT TELEPHONE CALL THAT I WOULD HEAR BACK FROM THEM SOON FOR AN APPOINTMENT TO CORRECT. NO RETURN CONTACT AS OF 24-JAN, 2023 0600A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5400 IBREEZE 25STA CONTINUOUS VENTILATOR, MINIMAL VENTILATORY SUPPORT QOR RESVENT MEDICAL TECHNOLOGY CO., LTD IBREEZE 25STA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other