BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE MEDICAL

    MDR report key: 18965564 · Received March 23, 2024

    Report

    Report Number
    3010838917-2024-00200
    Event Type
    Malfunction
    Date Received
    March 23, 2024
    Date of Event
    January 22, 2024
    Report Date
    March 22, 2024
    Manufacturer
    VYAIRE OY
    Product Code
    BTL
    UDI-DI
    10190752135680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAULTY PEEP VALVE COULD DELAY THERAPY TO PATIENT WHILE CLINICIAN SWITCHES THEM OUT. THIS WOULD PREVENT THE PATIENT FROM GETTING THE PROPER PEEP FLOW, THUS INTERRUPTING THERAPY. SUPPLIER INFORMED ABOUT THE COMPLAINT, NO FURTHER ACTION NEEDED. THIS IS AN OEM PRODUCT FROM MERCURY MEDICAL, HENCE INVESTIGATION SHALL BE CONDUCTED BY THE LEGAL MANUFACTURER, TASK REQUEST SHOULD BE LIMITED TO SUPPLIER COMMUNICATION. THEREFORE PLEASE REASSIGN IT TO ME AS SUCH SO THAT I CAN PERFORM THE TASK ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THE FAULTY PEEP VALVE COULD DELAY THERAPY TO PATIENT WHILE CLINICIAN SWITCHES THEM OUT. THIS WOULD PREVENT THE PATIENT FROM GETTING THE PROPER PEEP FLOW, THUS INTERRUPTING THERAPY.

    Description of Event or Problem · 0

    PEEP VALVE FAULTY. 3 CIRCUITS USED ON 2 DIFFERENT PANDA RESUSCITATORS WOULD ONLY PROVIDE 3 CMH2O OF PEEP DESPITE TURNING VALVE HIGHER AND HIGHER.  RECEIVED MEDWATCH REPORT 0700220000-2023-8422.

    Description of Event or Problem · 0

    PEEP VALVE FAULTY. 3 CIRCUITS USED ON 2 DIFFERENT PANDA RESUSCITATORS WOULD ONLY PROVIDE 3 CMH2O OF PEEP DESPITE TURNING VALVE HIGHER AND HIGHER.  RECEIVED MEDWATCH REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427066 VYAIRE MEDICAL T-PIECE NEONATAL CIRCUIT BTL VYAIRE OY M1091335VS 23207 10190752135680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other