BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILENT TECHNOLOGIES

    MDR report key: 321670 · Received March 16, 2001

    Report

    Report Number
    MW1021379
    Event Type
    Injury
    Date Received
    March 16, 2001
    Date of Event
    March 9, 2001
    Report Date
    March 16, 2001
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GAS ANALYZER FROM ANESTHESIA GAS MODULE (AGILENT) KEPT GOING INTO "ANALYZER STAND BY". UNABLE TO DUPLICATE PROBLEM AFTER MACHINE WAS SHUT DOWN. WHILE PT WAS CONNECTED TO MACHINE, UNABLE TO VIEW END TIDAL CO2, END TIDAL AGENT AND NIBP. PT BECAME HYPOTENSIVE; BROUGHT OUT OF ANESTHESIA AND TRANSFERRED SAFELY TO POST ANESTHESIA RECOVERY UNIT. DISCHARGED TO HOME THE NEXT DAY. THIS INCIDENT OCCURRED ON THE SECOND DAY THAT THIS BRAND NEW PIECE OF EQUIPMENT WAS IN SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11757 AGILENT TECHNOLOGIES ANESTHETIC GAS MODULE CCK AGILENT TECHNOLOGIES, INC. M 1026 A *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention