BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE¿ INFANT SINGLE LIMB HEATED WIRE CIRCUIT KIT

    MDR report key: 16908551 · Received May 10, 2023

    Report

    Report Number
    8030673-2023-00317
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    July 21, 2022
    Report Date
    May 10, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    OFP
    UDI-DI
    10190752145122
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT 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

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE HUMIDIFIER WAS NOT HEATING DUE TO A BENT PRONG ON AIRLIFE¿ INFANT SINGLE LIMB HEATED WIRE CIRCUIT KIT.THE REPORTED ISSUE OCCURRED DURING PATIENT USE AND THE CIRCUIT WAS CHANGED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882826 AIRLIFE¿ INFANT SINGLE LIMB HEATED WIRE CIRCUIT KIT ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) OFP VYAIRE MEDICAL CIRCUIT,INFANT SL,HTD CONTINUOUS-FLOW,CHAMBER 0004185830 10190752145122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention