BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 14403267 · Received May 14, 2022

    Report

    Report Number
    2021710-2022-15967
    Event Type
    Malfunction
    Date Received
    May 14, 2022
    Date of Event
    April 15, 2022
    Report Date
    April 15, 2022
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    LSZ
    UDI-DI
    10846446003079
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE AND WAS ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE. THIS IS AN ISSUE WITH VOLTAGES BEING SUPPLIED BY THE DPM. THE FSR MADE ADJUSTMENTS TO THE POT R18 ON THE DPM AND VERIFIED A MAX HZ OUTPUT OF 150. THE HZ WAS VERIFIED WITH A CALIBRATED DVM (DIGITAL VOLTMETER). THE FSR PERFORMED A CHECK UP OF THE PSU (POWER SUPPLY UNIT) AND THE VOLTAGES SUPPLIED ARE WITHIN MANUFACTURING SPECIFICATIONS. SLIGHT ADJUSTMENTS WERE MADE TO THE DDI (DYNAMIC DISPLACEMENT INDICATOR) BOARD. PATIENT CIRCUIT TEST AND PERFORMANCE TEST WERE DONE AND BOTH PASSED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FREQUENCY WILL NOT ADJUST TO MAXIMUM VALUE ON THE 3100 A DEVICE. 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
    1788107 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL INC. 3100 A 10846446003079

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown