BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 12775698 · Received November 8, 2021

    Report

    Report Number
    2021710-2021-14886
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    October 11, 2021
    Report Date
    January 28, 2022
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    LSZ
    UDI-DI
    10846446003543
    PMA / PMN Number
    P890057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B))(4). 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.

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT #: (B)(4). RESULTS OF INVESTIGATION: A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE AND VERIFIED THE REPORTED PROBLEM. AS A RESOLUTION, THE PNEUMATICS AND PRESSURE TRANSDUCER WERE RECALIBRATED. THE DEVICE PASSED ALL TESTING. 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

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL WHILE THE VELA VENTILATOR WAS RUNNING, ""VENT INOP/INOPERABLE"", ""MOTOR FAULT"", ""LOW PIP/PEAK INSPIRATORY PRESSURE"", AND ""XDCR/TRANSDUCER FAULT"" ALARM TRIGGERED. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT. 6. TESTS/LAB DATA, INCLUDING DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669177 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL 3100B 10846446003543

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention