BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 10820279 · Received November 10, 2020

    Report

    Report Number
    2021710-2020-12829
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 15, 2020
    Report Date
    October 15, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    LSZ
    UDI-DI
    10846446003543
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION AND IT DID NOT SHOW ANY PHYSICAL DAMAGE. THE PCBA WAS INSTALLED INTO A KNOWN GOOD 3100B TOP-LEVEL UNIT AND POWERED ON THEN AFTER A SUCCESSFUL CIRCUIT CALIBRATION THE SYSTEM WAS CYCLED FOR OVER 1 HOUR AND NO FUNCTIONAL ISSUES WERE REPRODUCED. USING OSCILLOSCOPE ID# (B)(6) (CAL DUE 04MAY22) AND NO FLUCTUATIONS OF OUTPUT FROM U7 PINS #1, #2 WERE FOUND. THE REPORTED ISSUE WAS NOT DUPLICATED.

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE AND EVALUATED THE VENTILATOR. IT WAS SEEN THAT DRIVER FOR 3 OHMS WITH A DVM IS OPEN. ORDER 3 OHMS DRIVER PRQ-(B)(4). NO ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME, SINCE THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR DOES NOT OSCILLATE. 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
    1281862 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL 3100B 10846446003543

    Patients

    Seq Age Sex Outcome Treatment
    1