BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL VENTILATOR

    MDR report key: 20177472 · Received September 9, 2024

    Report

    Report Number
    3013421741-2024-00399
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 9, 2024
    Manufacturer
    VYAIRE MEDICAL INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). D4: COMPLETE UDI# WAS NOT PROVIDED BY END USER. H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION, HOWEVER THE INVESTIGATION IS STILL ONGOING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: D9, G6, H2, H3, H6, H11. H3: FINDINGS/ROOT CAUSE: THE REPORTED COMPLAINT WAS VERIFIED AND DUPLICATED, DUE TO A FAULTY CAPACITOR COMPONENT C910 AND C909 P/N:13804-001.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE REVEL WAS COMING IN DUE TO A CONSTANT VENT INOP ALARM. THERE WAS NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336128 REVEL VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown