BEUDAMED
    FDA Adverse Event Death Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 13006341 · Received December 14, 2021

    Report

    Report Number
    2021710-2021-15039
    Event Type
    Death
    Date Received
    December 14, 2021
    Date of Event
    October 13, 2021
    Report Date
    November 16, 2021
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    LSZ
    UDI-DI
    10846446002317
    PMA / PMN Number
    P890057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. 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 WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE O2 (OXYGEN) BLENDER WAS NOT WORKING PROPERLY. INO (INHALED NITRIC OXIDE) WAS ADMINISTERED VIA INO DELIVERY DEVICE WITH HIGH FLOW OXYGEN BLENDER. THE BLENDER READ 100% HOWEVER THE ANALYZER READ 21%.THEY ATTEMPTED TO INCREASE OXYGENATION, THE INFANT SUSTAINED A PNEUMOTHORAX AND HEALTH DECLINED RAPIDLY AND THE PATIENT PASSED WITH PARENTS. THEY DISCOVERED THAT THE NUT RETAINING THE KNOB OF THE O2 BLENDER WAS LOOSE AND WAS NOT PROVIDING FRICTION FIT REQUIRED FOR ADJUSTMENT OF O2 CONCENTRATION. THE CUSTOMER CONFIRMED THAT THE HEALTH CARE PROVIDER ATTEMPTED TO INCREASE OXYGENATION. HOWEVER, THE INFANT'S HEALTH SUSTAINED PNEUMOTHORAX. INFANT'S HEALTH DECLINING RAPIDLY AND PASSED WITH PARENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897785 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL 3100A 10846446002317

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death