BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 13425751 · Received February 2, 2022

    Report

    Report Number
    2021710-2022-15436
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 5, 2022
    Report Date
    January 5, 2022
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001419
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11-ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER REVEALED THAT THE REPORTED ISSUE OCCURRED DURING PREVENTIVE MAINTENANCE. PLEASE DISREGARD AND VOID VYAIRE REFERENCE NUMBER:(B)(4) UNDER MEDWATCH REPORT NAME:MWR-20012022-0000011930.

    Additional Manufacturer Narrative · 0

    (B)(4). A VYAIRE FIELD SERVICE REPRESENTATIVE(FSR) EVALUATED THE DEVICE ONSITE AND WAS ABLE TO VERIFY THAT THE VALUES ARE MUCH LOWER THAN THE 20% +/- FOR VTE (END-TIDAL VOLUME). THE EXHALATION PRESSURE TRANSDUCER WAS CALIBRATED,PASSED AND ACCEPTED BY THE UNIT BUT IT DID NOT RESOLVE THE LOW VTE ISSUE. THE EXHALATION FLOW TRANSDUCER WAS ALSO CALIBRATED BUT CANNOT GET A READING ON THE CITREX H5 TO APPLY 3CMH20. WHEN APPLYING PRESSURE, THE CITREX VALUES FOR CMH20 TO NOT MOVE, STAYS AT ZERO. UPON FURTHER INSPECTION, THE CONNECTOR ASSEMBLY FOR THE FLOW SENSOR WAS MISSING THEIR O-RINGS, DESPITE THE UNIT PASSING THE LEAK TEST. THE UNIT WAS REPLACED,OVP (OPERATIONAL VERIFICATION PROCEDURE) WAS PERFORMED AND VERIFIED THAT ALL VALUES ARE WITHIN SPECIFICATIONS. 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 THAT THE VOLUMES ARE VERY LOW ON THE VELA VENTILATOR. IT WAS SET @500 BUT READING IN THE 200'S. 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
    60481 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown