BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEL VENTILATOR

    MDR report key: 19209961 · Received April 29, 2024

    Report

    Report Number
    2021710-2024-19065
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    April 4, 2024
    Report Date
    April 29, 2024
    Manufacturer
    VYAIRE MEDICAL, INC PALM SPRINGS
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE INDENTIFICATION: (B)(4). H3: 81 OTHER ¿ CURRENTLY, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, A ROOT CAUSE HAS NOT BEEN DETERMINED. NO PATIENT INVOLVEMENT. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE INDENTIFICATION: (B)(4). H3: 81 OTHER ¿ CURRENTLY, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, A ROOT CAUSE HAS NOT BEEN DETERMINED. NO PATIENT INVOLVEMENT. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL HE LEDS ALL LIGHT UP AND BACK OFF AND THEN GO ONE-AT-A-TIME CLOCKWISE FROM ONE SETTING TO THE NEXT. THERE WERE NO ALARMS AND THE VENTILATOR KEPT VENTILATING THE PATIENT (NO PATIENT HARM REPORTED). THEY SWAPPED IT OUT WITH ANOTHER VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030043 REVEL VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC PALM SPRINGS REVEL, ENGLISH SERVICE REPAIR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention