BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100A VENT

    MDR report key: 21627259 · Received March 17, 2025

    Report

    Report Number
    3013421741-2025-00622
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 17, 2025
    Manufacturer
    VYAIRE MEDICAL INC
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FILE IDENTIFICATION: (B)(4). D4: DEVICE WAS MANUFACTURED IN 1997 AND WAS NOT SUBJECT TO UDI REQUIREMENTS. H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION UPDATE: G3, G6, H2, H6, AND H11. RESULTS OF INVESTIGATION: AN FSE VISITED THE CUSTOMER SITE TO EVALUATE THE DEVICE AND CONFIRMED THE REPORTED ISSUE. HOWEVER, THE ISSUE REMAINS UNRESOLVED, AND THE ROOT CAUSE HAS NOT YET BEEN ESTABLISHED. A REPLACEMENT PART WAS ORDERED TO RESOLVE THE ISSUE; HOWEVER, AT THIS TIME, NO FURTHER UPDATES ON THE RESOLUTION HAVE BEEN RECEIVED. A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CGR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DELTA P WAS DECREASING WHILE VENTILATING A PATIENT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804622 3100A VENT VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL INC 768901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown