BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT

    MDR report key: 12490642 · Received September 17, 2021

    Report

    Report Number
    8030673-2021-00200
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 20, 2021
    Report Date
    August 20, 2021
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CAI
    UDI-DI
    10190752120792
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION:THE DEVICE HISTORY RECORD WAS REVIEWED IN ORDER TO DETECT ANY ISSUE RELATED WITH THE DEFECT REPORTED BY THE CUSTOMER DURING ITS MANUFACTURING. ACCORDING TO INVESTIGATION, WE DETERMINED THAT EQUIPMENT AND MATERIAL ARE RELATED TO REPORTED DEFECT: MOLD ( M-166S) IS RELATED TO REPORTED DEFECT, SINCE FOUND SOME CAVITIES IN THE MINIMUM IN SAMPLE FROM PRODUCTION AND THE SAMPLES PROVIDED FOR THE INVESTIGATION FOUND SOME CAVITIES OUT OF SPECIFICATION. THE MOLD WAS REVIEWED AND FOUND THAT SOME CAVITIES ARE IN THE MINIMUM AND IT CAN CAUSE THAT SOME CAVITIES ARE IN THE MINIMUM DIMENSIONAL OR OUT OF SPECIFICATION. 3 CLOSED SAMPLES WERE RECEIVED FOR EVALUATION AND AN ADDITIONAL 2 SAMPLES WERE RECEIVED AS WELL. ON THE 3 SAMPLES RECEIVED 2 ELBOWS AND 1 FILTER ARE OUT OF SPECIFICATION. WHILE FROM THE ADDITIONAL SAMPLES RECEIVED 1 ELBOW AND 2 FILTERS ARE OUT OF SPECIFICATION. THEREFORE THE REPORTED DEFECT WAS CONFIRMED. THE ROOT CAUSE IS THE MATERIAL DOES NOT MEET THE MANUFACTURER'S SPECIFICATIONS. THE ELBOW IS MANUFACTURED IN MEXICALI WHILE THE FILTER IS MANUFACTURED AND PROVIDED BY AN EXTERNAL SUPPLIER.

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. 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

    THE CUSTOMER REPORTED A LOOSE CONNECTION BETWEEN THE ELBOW AND THE HMU FILTER RESULTED TO A DETACHMENT OF THE GSE FROM EDITH 1000 HME AND EDITH 1000 HME FROM THE PATIENT WYE ON THE SUTTER HEALTH FORMULARY A5U580A4 VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT, LOT 0004188508. MOST TIMES THE OPERATING TIME IS INCREASED DUE TO THE CIRCUIT FALLING APART. AND FOR THIS REPORTED INCIDENT, THE ISSUE CAUSED A DISRUPTIONS AND ROOM GAS CONTAMINATION DURING SURGERY. THE ISSUE OCCURRED DURING PATIENT-USE AND AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390344 VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI VYAIRE MEDICAL VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT 0004188508 10190752120792

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown