BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA

    MDR report key: 12840824 · Received November 18, 2021

    Report

    Report Number
    2021710-2021-14865
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    October 21, 2021
    Report Date
    October 21, 2021
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    10846446001419
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS ABLE TO CONFIRM THE ISSUE, AND NO VISIBLE DEFECTS, DAMAGE, OR CONTAMINATION WERE FOUND. THE COMPONENT WAS INSTALLED IN A KNOWN GOOD UNIT AND WAS POWERED ON IN USER MODE, WHERE IT WOULD AUTO CYCLE AND ALARM TRANSDUCER FAULT. CALIBRATIONS WERE PERFORMED AS DESCRIBED IN THE VENTILATOR SYSTEMS SERVICE MANUAL AND WERE SUCCESSFULLY CALIBRATED AND IMMEDIATELY AFTER THE ODV WAS MEASURED, THE CALIBRATION WAS RE-PERFORMED AND TRANSDUCER FAILED. THE REPORTED COMPLAINT WAS CONFIRMED IN THE EVENT LOG AND DUPLICATED DURING FUNCTIONAL TESTING. THE PT802 TRANSDUCER HAS FAILED. THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) FOR THE VELA WILL BE PUT ON HOLD. REFERENCE CAPA: CA-2017-0206. THE PARTS WILL BE REPLACED UNDER WARRANTY. AN ORDER WAS PLACED AND PART WAS SHIPPED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, LOG FILE SHOWS THAT AN XDCR FAULT OCCURRED, PERFORMED XDCR TESTS AND ALL PASSED. CALIBRATION OF THE EXHAL DIFF PRESS FAILED AT 0 CMH2O. THE PARTS WILL BE REPLACED UNDER WARRANTY. NO 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR WAS HAVING AN ALARM XDCR/TRANSDUCER FAULT WHILE CONNECTED TO A PATIENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737830 VELA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. VELA 10846446001419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention