BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRI AIRMIX STAGE 5 RESPIRATORY COMPONENT

    MDR report key: 18935759 · Received March 19, 2024

    Report

    Report Number
    3012307300-2024-01484
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 21, 2024
    Report Date
    March 19, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTL
    UDI-DI
    335019315074718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE AFFECTED DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. AFTER VISUAL INSPECTION, FUNCTIONAL TESTS WERE PERFORMED. TESTING WAS PERFORMED WITH G:02467-CZ,G:02468-CZ, G:02371-CZ, G:02371-CZ, AND G:03491-CZ. THE DEVICE FAILED TESTS 6.2 RELIEF VALVE-OVER LIMIT, AND 6.4 CARRY OUT BACKPRESSURE LEAK TEST-LEAK MORE THAN 10. THE CUSTOMER'S INDICATED FAILURE WAS CONFIRMED, AND THE ROOT CAUSE WAS THE PATIENT VALVE AND A LEAK IN THE RELIEF VALVE. AS A RESULT, THE PATIENT VALVE AND RELIEF VALVE WILL BE REPLACED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ¿BACKPRESSURE LEAK TEST PATIENT CIRCUIT LEAK CHECK DIFFERENCE 16ML¿. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536866 VRI AIRMIX STAGE 5 RESPIRATORY COMPONENT VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL ASD, INC. 335019315074718

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown