BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESVENT IBREEZE

    MDR report key: 20370023 · Received October 3, 2024

    Report

    Report Number
    MW5160573
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    September 20, 2024
    Report Date
    September 27, 2024
    Manufacturer
    RESVENT MEDICAL TECHNOLOGY CO., LTD.
    Product Code
    QOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I NOTICED A LARGE BURN MARK WITH REMOVAL OF FINISH ON MY WOODEN NIGHT TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602450 RESVENT IBREEZE NON-CONTINUOUS VENTILATOR FOR EMERGENCY USE QOQ RESVENT MEDICAL TECHNOLOGY CO., LTD. IBREEZE20A 2022-08-01

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female A CPAP.