BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS/3 ADU

    MDR report key: 398110 · Received June 3, 2002

    Report

    Report Number
    9616013-2002-00001
    Event Type
    Injury
    Date Received
    June 3, 2002
    Date of Event
    May 15, 2002
    Report Date
    May 31, 2002
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DIFFICULTY VENTILATING A PATIENT DURING A CASE. INVESTIGATION/CONCLUSION: THE EQUIPMENT WAS CHECKED OUT BE DATEX-OHMEDA SERVICE REPRESENTATIVES AND FOUND TO FUNCTION WITHIN MANUFACTURER'S SPECIFICATIONS. FOLLOWING THE CHECKOUT, DATEX-OHMEDA WAS INFORMED BY THE CUSTOMER THAT THE HOSES WERE MISCONNECTED DURING THE ALLEGED EVENT. DURING DATEX-OHMEDA'S INVESTIGATION OF THE ALLEGED EVENT, THE HOSES WERE MISCONNECTED AS DESCRIBED BY THE CUSTOMER. WITH THE EQUIPMENT CONFIGURED IN SUCH A MANNER, VENTILATION OF THE PATIENT WOULD NOT BE POSSIBLE. PROPER EQUIPMENT SETUP AND SYSTEM CHECKOUT PROCEDURES ARE CONTAINED IN THE ADU USER MANUAL. 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, MFR, 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR