BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 12319645 · Received August 13, 2021

    Report

    Report Number
    2021710-2021-14351
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 19, 2021
    Report Date
    July 19, 2021
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    LSZ
    UDI-DI
    10846446003079
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE FILE IDENTIFICATION: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. HOWEVER, THE CUSTOMER TROUBLESHOOTED THE UNIT WITH THE TECHNICAL SUPPORT'S ASSISTANCE AND AND FOUND THAT WHEN HE SWAPPED THE LIMIT AND THE CONTROL THE LIMIT SWITCH STARTED TO ADJUST. THE PR2 MIGHT BE THE CULPRIT. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT MEAN AIRWAY PRESSURE (MAP) OF THE 3100A VENTILATOR IS HAVING ISSUES AND THE LIMIT IS NOT ADJUSTING. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216987 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL 3100A 10846446003079

    Patients

    Seq Age Sex Outcome Treatment
    1