BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 9714668 · Received February 14, 2020

    Report

    Report Number
    2021710-2020-11392
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 6, 2020
    Report Date
    January 17, 2020
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    70846446001442
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THE VELA MAIN PCBA WAS RECEIVED AT THE VYAIRE MEDICAL FACILITY. THE SERVICE TECHNICIAN VERIFIED THE REPORTED PROBLEM. THERE WERE NO VISIBLE DEFECTS, DAMAGE OR CONTAMINATION. ATTEMPTED TO CONFIRM REPORTED PROBLEM "XDUCR FAULTS". COMPONENT WAS INSTALLED IN KNOWN GOOD VELA UNIT. VENTILATOR WAS POWERED IN VENTILATE WHERE UNIT DID NOT VENTILATE AND ALARM THE FOLLOWING: MOTOR FAULT, APNEA INTERVAL, HIGH PEEP, HIH PIP AND LOW VE. THE REPORTED COMPLAINT WAS CONFIRMED THROUGH THE EVENTS LOG AND DUPLICATED DURING FUNCTIONAL CHECK. (B)(4) HAS FAILED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE TECHNICAL SUPPORT HAS REQUESTED THE CUSTOMER TO RETURN THE SUSPECT DEVICE TO THE FA-LAB FACILITY FOR REPAIR AND FURTHER INVESTIGATION. AT THIS TIME, NO ROOT CAUSE HAS BEEN DETERMINED. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR VELA VENTILATOR WAS ALARMING CONSTANT TRANSDUCER XDCR FAULT. THE CUSTOMER CLAIMED THAT THE PROBLEM IS THE MAIN PCB. THERE IS NO PATIENT INVOLVEMENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176314 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. VELA 70846446001442

    Patients

    Seq Age Sex Outcome Treatment
    1