BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC VRI AIRMIX STAGE 5

    MDR report key: 18727293 · Received February 16, 2024

    Report

    Report Number
    9611178-2024-00053
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 1, 2024
    Report Date
    February 16, 2024
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTL
    PMA / PMN Number
    K071527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. D5. OTHER OPERATOR OF DEVICE: OPERATOR OF DEVICE IS UNKNOWN. INVESTIGATION SUMMARY: THE AFFECTED DEVICE WAS RETURNED FOR EVALUATION AND WAS FOUND TO BE IN GOOD PHYSICAL CONDITION. AFTER VISUAL INSPECTION, FUNCTIONAL TESTING WAS PERFORMED, TURNING ON THE FOLLOWING STATIONS: G:02367-CZ, G:02337-CZ, G:02468-CZ, G:02514-CZ, AND G:02371-CZ. THE DEVICE FAILED THE RELIEF TEST ON THE CHILD SETTING, TIDAL VOLUME TEST, AND LEAK TEST. THE CUSTOMER'S INDICATED FAILURE WAS DUPLICATED AND CONFIRMED, AND THE ROOT CAUSE WAS FOUND TO BE THE RELIEF VALVE OVER LIMIT. AS A RESULT, THE RELIEF VALVE WILL BE REPLACED AND THE SELECTOR DISC WILL BE CLEANED OR REPLACED IF NEEDED. AFTER REPAIR THE DEVICE MUST PASS ALL FUNCTIONAL TESTS BEFORE IT WILL BE SHIPPED BACK TO THE CUSTOMER. 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 RELIEF VALVE WAS OUT OF RANGE DURING AN ANNUAL CHECK. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431564 PNEUPAC VRI AIRMIX STAGE 5 VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL INTERNATIONAL LTD. 520A1126NESNONEU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown