BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 16835155 · Received April 28, 2023

    Report

    Report Number
    2021710-2023-17589
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    March 28, 2023
    Report Date
    April 28, 2023
    Manufacturer
    VYAIRE MEDICAL
    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

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, 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 BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: VISUAL INSPECTION WAS PERFORMED AND FOUND NO INDICATIONS OF DAMAGE, MISUSE, OR CONTAMINATION. PCB WAS INSTALLED INTO A KNOWN GOOD TOP-LEVEL VELA TEST UNIT AND POWERED ON INTO SERVICE MODE. ALL OCCURRENCES WERE FOUND TO BE FOR PT801 TRANSDUCER (EXH PRESS) AS STATED BY CUSTOMER. THE REPORTED WAS CONFIRMED. EXH PRESS TRANSDUCER AT LOCATION PT801 WAS FOUND TO FAIL ZERO CALIBRATION. THIS IS A KNOWN ISSUE THAT HAS BEEN ADDRESSED WITH CAPA-000000281 SCAR PS-16-23. 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

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS TRANSDUCER FAULT ALARM AND FAILS EXHALATION PRESSURE CALIBRATION AT 0. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737428 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA VENTILATOR 70846446001442

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown