BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT ULTRA FLEX

    MDR report key: 1048169 · Received May 19, 2008

    Report

    Report Number
    MW5006944
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 19, 2008
    Manufacturer
    KING SYSTEMS CORPORATION
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A LEAK TEST ON AN ADULT BREATHING CIRCUIT -ADULT ULTRA FLEX ANESTHESIA BREATHING CIRCUIT BY KING SYSTEMS CORP REF # 8903F-425Z / LOT# IKMQ4- BOTH THE INSPIRATORY AND EXPIRATORY HOSES DISLODGED QUITE EASILY FROM THE BI-FURCATION POINT WHEN EXPANDING THE HOSES FOR USE. WHEN A RE-ATTACHMENT WAS MADE TO THE CIRCUIT, THE HOSES WERE THEN TESTED AGAIN FOR EASY DISLODGEMENT. AGAIN, THE HOSES DETACHED FROM THE CIRCUIT WITHOUT DIFFICULTY. THIS CAN POSE A POTENTIAL LIFE THREATENING SITUATION IF THE CIRCUIT CAN BE DISLODGED EASILY DURING A SURGICAL PROCEDURE WHILE THE PATIENT IS INTUBATED. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: PATIENT UNDER GENERAL ANESTHESIA. EVENT REAPPEARED AFTER REINTRODUCTIONS? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT ULTRA FLEX ANESTHESIA BREATHING CIRCUIT CAI KING SYSTEMS CORPORATION IKMQ4

    Patients

    Seq Age Sex Outcome Treatment
    1