BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS

    MDR report key: 19732000 · Received July 12, 2024

    Report

    Report Number
    8030673-2024-01014
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 13, 2024
    Report Date
    August 9, 2024
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CAI
    UDI-DI
    10190752118188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 12 JULY 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 12 JULY 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. SINCE THE REPORTED DEFECT WAS CONFIRMED AND THE ROOT CAUSE ESTABLISHED THE FOLLOWING ACTIONS WERE ESTABLISHED: 1. ASSEMBLY PERSONNEL WERE RETRAINED ON SPM 5161 ETAL. 2. SPM 5161 ETAL WILL BE MODIFIED TO INSTRUCT THE PROPER METHOD OF ASSEMBLY OF FG 1552016. 3. ALCOHOL PART NUMBER 70-013A WILL BE REMOVED FROM THE BOM THE ASSEMBLY OF 1552016 UNDER (B)(4). 4. PFMEA-58A-022 WILL BE REVIEWED. ADDITIONALLY, ASSEMBLY PERSONNEL WERE NOTIFIED ABOUT THE COMPLAINT."

    Description of Event or Problem · 0

    THE CONNECTIONS AT THE BLUE AND WHITE TUBBING SEPARATED VERY EASILY.

    Description of Event or Problem · 0

    THE CONNECTIONS AT THE BLUE AND WHITE TUBBING SEPARATED VERY EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384688 VITAL SIGNS VITAL SIGNS¿ PEDIATRIC ANETHESIA BREATHING CIRCUIT CAI VYAIRE MEDICAL INC. 1552016 2023-03-13 10190752118188

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other