BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 14881703 · Received June 30, 2022

    Report

    Report Number
    2021710-2022-16318
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    June 20, 2022
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    10846446066074
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    RESULTS OF INVESTIGATION: VYAIRE FSR (FIELD SERVICE REPRESENTATIVE) PERFORMED WORK ORDER FOR THIS VENT. VENT FAILED EXH VALVE CHARACTERIZATION 3 TIMES. VENT ALSO HAS A EXTERNAL BATTERY CHARGING PROBLEM. FSR ONSITE ON 08/18/22, ALL PARTS ARRIVED ONSITE. PULLED AVEA VENT BODY OFF STAND, REPLACED INTERNAL POWER CABLE. FOUND OLD CABLE PINCHED AND CUT. REPLACED EXTERNAL BATTERY PACKS AS WELL. RETURNED VENT BODY BACK TO STAND. PULLED TOP DOWN AND INTO VENT. REPLACED EXH VALVE ASSEMBLY. VENT PREVIOUSLY FAILED EXH VALVE CHARACTERIZATION 3 TIMES. CHECKED ALL CONNECTIONS. BROUGHT VENT UP. INTO SERVICE MODE AND CALLED TECH SUPPORT FOR CALIBRATION CODES. INTO TUNNING MENU AND EXH VALVE CHARACTERIZATION AND WAS ABLE TO RAN THIS. NOW IT PASSED FIRST TIME. BROUGHT VENT BACK UP TO NORMAL BOOT UP. RAN THROUGH EST (EXTENDED SYSTEMS TESTS) MULTIPLE TIMES WITHOUT ISSUES. RAN VENT FOR 2 HOURS WITHOUT ANY ISSUES. CHECK ALL ALARMS AND ALL PASSED. VERIFIED VENT NOW WORKING WITHIN MANUFACTERS SPECIFICATIONS. INTERNAL AND EXTERNAL BATTERIES CHARGING AND BOTH LEDS WORKING. VENT SETTINGS VERSUS MEASURED ARE WITHIN SPECIFICATIONS. ALL ALARMS PASSED. 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 PROBLEM WITH AVEA VENTILATOR ALARMING CIRCUIT DISCONNECT. THE END-USER CHANGED THE CIRCUIT AND THAT DID NOT CORRECT THE ISSUE. CUSTOMER IS NOT SURE IF THE CIRCUIT DISCONNECT WAS NOTED BEFORE PLACING THE PATIENT ON THE UNIT OR AFTER. NEVERTHELESS, THE PATIENT WAS PLACED ON ANOTHER UNIT WITH NO HARM NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280655 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. AVEA II 10846446066074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention