BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEC 6 NAD VARIANT

    MDR report key: 538329 · Received August 6, 2004

    Report

    Report Number
    2112667-2004-00065
    Event Type
    Death
    Date Received
    August 6, 2004
    Date of Event
    July 16, 2004
    Report Date
    August 5, 2004
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY FELT THE OUTPUT OF THEIR VAPORIZER WAS LOWER THAN EXPECTED. THERE WAS NO REPORTED PT INJURY. INVESTIGATION/CONCLUSION: THE UNIT WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED. DURING THE INVESTIGATION, IT WAS NOTED THAT THERE WAS A FAULT WITH THE ROTARY VALVE. INVESTIGATIONS OF SIMILAR VALVES DETERMINED THAT IT HAS BEEN SUBJECTED TO SCRATCHING OF ITS SEALING FACE. THIS VALVE WAS MANUFACTURED BY ANOTHER MFR AND HAD THE GRAPHITE PROCESS APPLIED. PREVIOUS INVESTIGATIONS FOUND SOME DEVA MATERIAL CONTAINED AREAS OF LARGER DEPOSITS OF GRAPHITE THAT COULD BE REMOVED. NO FOREIGN MATERIAL OR GRAPHITE WAS FOUND TO DETERMINE THE CAUSE OF THE SCRATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 6 NAD VARIANT CALIBRATED VAPORIZER CAD DATEX-OHMEDA, INC. TEC 6 NAD VARIANT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA