BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 6

    MDR report key: 2964142 · Received February 8, 2013

    Report

    Report Number
    MW5028972
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    DATEX OHMEDA GE HEALTHCARE
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    HIGH VOLUME FAILURE OF ANESTHETIC VAPORIZERS WITHIN A SHORT PERIOD OF TIME - 17 DEVICES BETWEEN (B)(6) 2013. ALL RESULTED IN A FAILED LOW PRESSURE LEAK TEST ON THE DEVICE. TEC 6 PLUS - SERIAL #'S: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54787 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54788 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA
    54789 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54790 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54791 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54792 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54793 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54794 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54795 TEC 7 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54944 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54945 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54946 TEC 7 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54947 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54948 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54949 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54950 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE
    54951 TEC 6 ANESTHETIC VAPORIZERS CAD DATEX OHMEDA GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1