BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESVENT IBREEZE 20A

    MDR report key: 20038153 · Received August 21, 2024

    Report

    Report Number
    MW5158714
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    August 1, 2022
    Report Date
    August 19, 2024
    Manufacturer
    RESVENT MEDICAL TECHNOLOGY CO., LTD.
    Product Code
    QOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I'M NOT SURE OF THE FIRST DATE OF ISSUE SINCE I ASSUMED THE FIRST FEW ISSUES WERE USER ERROR. THIS HAS HAPPENED MULTIPLE TIMES. THIS MACHINE TURNS ON RANDOMLY AND WITHOUT PROVOCATION AND HAS DONE SO ON MANY PREVIOUS OCCASIONS. NO ONE IS USING IT, TOUCHING IT, OR INTERACTING WITH IT AND IT TURNS ON. IN ADDITION, THE HUMIDITY SETTINGS FLOOD THE TUBING WITH WATER, NO MATTER HOW LOW THE SETTING IS. AUTO SETTING FLOODS THE TUBING, RESULTING IN ME (THE PATIENT) BREATHING IN WATER WHILE ASLEEP. I REPORTED THIS TO THE MANUFACTURER, BUT THEY TOLD ME THAT THEY COULD NOT DO ANYTHING SINCE I NOW OWNED THE MACHINE AFTER HAVING IT FOR SO LONG. THESE ARE MEDICAL DEVICE PRODUCT DEFECTS. MY PRESCRIPTION MEDICATION IS NOT CAUSING THIS MACHINE TO TURN ON WITHOUT PROVOCATION. NOR IS IT CAUSING THE MACHINE TO FLOOD THE TUBING. NOT APPLICABLE TO A MEDICAL DEVICE THAT TURNS ON WHENEVER IT WANTS OR THE FLOODING OF THE CPAP TUBING. OF NOTE, I REPORTED THIS ADVERSE EVENT TO THE PHILIPS RESPIRONICS TEAM AND I DO NOT HAVE CONFIDENCE THAT THEY DOCUMENTED AND REPORTED THIS AE BASED ON THE DISCUSSION WITH THEIR AGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363744 RESVENT IBREEZE 20A CONTINUOUS VENTILATOR, MINIMAL VENTILATORY SUPPORT QOR RESVENT MEDICAL TECHNOLOGY CO., LTD. IBREEZE20A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention