BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX

    MDR report key: 2913121 · Received December 17, 2012

    Report

    Report Number
    2913121
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 17, 2012
    Manufacturer
    KING SYSTEMS
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE THE CRNA WAS PREPARING THE ANESTHESIA BREATHING CIRCUIT FOR USE, THE SAMPLE LINE PORT WAS DISCOVERED TO BE BROKEN/DEFECTIVE. IT WAS NOT BEING USED AT THE TIME, AND THERE WAS NO PATIENT IMPACT.======================MANUFACTURER RESPONSE FOR ADULT ANESTHESIA BREATHING CIRCUIT, ADULT ULTRA FLEX (PER SITE REPORTER).======================THEY ARE WAITING TO GET THE PRODUCT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ADULT ANESTHESIA BREATHING CIRCUIT CAI KING SYSTEMS * 10J8U

    Patients

    Seq Age Sex Outcome Treatment
    1 *