BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS/3 ADU

    MDR report key: 269239 · Received March 8, 2000

    Report

    Report Number
    9616013-2000-00001
    Event Type
    Malfunction
    Date Received
    March 8, 2000
    Date of Event
    February 21, 2000
    Report Date
    March 6, 2000
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNIT STARTED TO SMOKE WHILE LOCATED IN ANESTHESIA WORKROOM. THERE WAS NO PT INVOLVEMENT. DATEX-OHMEDA'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOWUP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. THE ADU (ANESTHESIA DELIVERY SYSTEM) IS DESIGNED AND MFG BY DATEX-OHMEDA, BROMMA, SWEDEN, AND IS DISTRIBUTED FOR SALE IN THE UNITED STATES BY DATEX-OHMEDA, INC., NORTH AMERICA. THIS MDR IS BEING FILED ON BEHALF OF THE MFR LOCATED IN BROMMA, SWEDEN. ALL RECORDS REGARDING THE DESIGN, MANUFACTURE, AND COMPLAINT INVESTIGATION OF THE ADU ARE LOCATED IN BROMMA, SWEDEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS/3 ADU ANESTHESIA MACHINE BSZ DATEX-OHMEDA AS/3 ADU NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA