BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE MEDICAL

    MDR report key: 18965559 · Received March 23, 2024

    Report

    Report Number
    8030673-2024-01003
    Event Type
    Malfunction
    Date Received
    March 23, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 22, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZA
    UDI-DI
    10190752152595
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE AS THIS COULD CAUSE AN AIR LINK AND DELAY PATIENT VENTILATION. THE COMPLAINT OF "THE PLASTIC CAP THAT IS ATTACHED DOES NOT STAY CLOSED AND POPS OPEN WITH ANY BREATH DELIVERED BY THE VENTILATOR." REGARDING PART 004081 WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN NO OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Additional Manufacturer Narrative · 0

    REPORTABLE AS THIS COULD CAUSE AN AIR LINK AND DELAY PATIENT VENTILATION.

    Description of Event or Problem · 0

    THE PLASTIC CAP THAT IS ATTACHED DOES NOT STAY CLOSED AND POPS OPEN WITH ANY BREATH DELIVERED BY THE VENTILATOR.  REPORT INDICATES THIS IS ADVERSE EVENT, BUT DOES NOT INDICATE ADVERSE EFFECT ON THE PATIENT.

    Description of Event or Problem · 0

    THE PLASTIC CAP THAT IS ATTACHED DOES NOT STAY CLOSED AND POPS OPEN WITH ANY BREATH DELIVERED BY THE VENTILATOR.  REPORT INDICATES THIS IS ADVERSE EVENT, BUT DOES NOT INDICATE ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700086 VYAIRE MEDICAL STRAIGHT CONN 22ODX22ID,W/PORT BZA VYAIRE MEDICAL 004081 0004254980 10190752152595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other