BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT

    MDR report key: 18735953 · Received February 19, 2024

    Report

    Report Number
    8030673-2024-00376
    Event Type
    Malfunction
    Date Received
    February 19, 2024
    Date of Event
    January 29, 2024
    Report Date
    February 19, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 81 OTHER - CUSTOMER DID NOT SEND A PHYSICAL SAMPLE OR PICTURES OF THE FG (B)(6).X WITH LOT NUMBER UNKNOWN FOR THE INVESTIGATION. WE REQUIRE A PHYSICAL SAMPLE OR PICTURES TO PERFORM A BETTER INVESTIGATION AND DETERMINE THE REPORTED DEFECT AND THE ROOT CAUSE. IN ADDITION, THE DEVICE HISTORY RECORD IS REVIEWED AS PART OF THE INVESTIGATION. HOWEVER, SINCE THE LOT NUMBER WAS NOT PROVIDED THIS WAS NOT POSSIBLE.THEREFORE, THE REPORTED DEFECT WAS NOT CONFIRMED. 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

    IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING USE ON PATIENT, LEAK OCCURRED ON FROM ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG.AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087549 VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI VYAIRE MEDICAL ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown