BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 6 PLUS VAPORIZER

    MDR report key: 1963753 · Received January 11, 2011

    Report

    Report Number
    MW5019008
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    GE DATEX OHMEDA
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    UNACCEPTABLE RATE OF FAILURE OF LEAK TEST OF ANESTHESIA EQUIPMENT. GE TEC 6 PLUS DESFLURANE VAPORIZER USED WITH A GE AVANCE ANESTHESIA MACHINE. THE AVANCE HAS A BUILT-IN SEMI-AUTOMATED LEAK TEST, CALLED THE "LOW P LEAK TEST". WE HAVE HAD FREQUENT REPEATABLE FAILURES WHEN THE DESFLURANE VAPORIZER IS INCLUDED AS PRESCRIBED IN THIS TEST, SET TO 1%. THESE FAILURES CAN CAUSE DELAYS IN SURGICAL CASES, OR NOT HAVING NEEDED EQUIPMENT AVAILABLE. WE HAVE HAD 14 VAPORIZERS FAIL AND BE REPLACED IN THE LAST 9 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 6 PLUS VAPORIZER TEC 6 PLUS VAPORIZER FOR DESFLURANE CAD GE DATEX OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1