BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESVENT IBREEZE PAP (POSITIVE AIRWAY PRESSURE)

    MDR report key: 18274512 · Received December 5, 2023

    Report

    Report Number
    MW5148855
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 1, 2023
    Manufacturer
    RESVENT MEDICAL TECHNOLOGY CO., LTD.
    Product Code
    QOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WAS SWITCHED FROM A PHILIPS DREAMSTATION 2 BY DME (DURABLE MEDICAL EQUIPMENT) PROVIDER TO A RESVENT IBREEZE CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) MACHINE. DEVICE DOESN'T INCREASE PRESSURES ADEQUATELY TO CONTROL FLOW LIMITATIONS. DEVICE IS EXCESSIVELY LOUD TO THE POINT WHERE YOU CAN HEAR MY FAMILY MEMBER BREATHING IN AND BREATHING OUT. SEE ATTACHED SCREENSHOT FOR PRESSURE CURVES/FLOW LIMITATION FLAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258291 RESVENT IBREEZE PAP (POSITIVE AIRWAY PRESSURE) CONTINUOUS VENTILATOR, MINIMAL VENTILATORY SUPPORT QOR RESVENT MEDICAL TECHNOLOGY CO., LTD. 20A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Disability ADVAIR.| ASPIRIN.| CLOZAPINE.| LANSOPRAZOLE.| METOPROLOL.| NEBULIZED ALBUTEROL.| PREDNISONE.| RESVENT IBREEZE PAP (POSITIVE AIRWAY PRESSURE) DEVICE.| TORSEMIDE.| VITAMIN D 1000 IU.