BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2M ASSY, PKG, REVEL, GRN, DISS, ENGL

    MDR report key: 19169865 · Received April 24, 2024

    Report

    Report Number
    2021710-2024-19049
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 23, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    00845873000029
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION:(B)(4). H3: 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

    DEVICE EVALUATION: FINDING/ROOT-CAUSE: REPORTED COMPLAINT WAS VERIFIED AND DUPLICATED. THIS WAS ISOLATED TO CAPACITORS P/N:13804-001 AND HAS BEEN ADDRESSED BY CAPA-000000497.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT UPON GOING TO START UP THE VENT IT BEGAN BEEPING AND VENT INOP LIGHT IS SEEING FLASHING RED ALONG WITH THE CONTROL LOCK, MANUAL BREATH, AND MANEUVERS BUTTONS ALL BEING LIT UP GREEN. THE VENT CYCLED ON TWICE WITH THE LED SCREEN LIGHTING UP FOR A SECOND BUT THEN SHUTTING OFF (GOING BLANK) IMMEDIATELY AFTER BOTH TIMES. NO PATIENT INVOLVEMENT, ISSUE FOUND DURING START-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083494 M2M ASSY, PKG, REVEL, GRN, DISS, ENGL VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL REVEL, GRN, DISS, ENGL 00845873000029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown