BEUDAMED
    FDA Adverse Event Death Summary report: N

    OHMEDA OXYGEN OUTLET

    MDR report key: 193245 · Received October 23, 1998

    Report

    Report Number
    193245
    Event Type
    Death
    Date Received
    October 23, 1998
    Date of Event
    September 26, 1998
    Report Date
    October 20, 1998
    Manufacturer
    MEDAES INC. (FORMERLY OHMEDA MEDICAL ENGINEERING SYSTEMS)
    Product Code
    CCN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE MAY HAVE CONTRIBUTED TO PT'S DEMISE BY ALLOWING THE INTRODUCTION OF AIR INTO THE ABDOMEN. THE EVENT MAY BE ATTRIBUTABLE TO OPERATOR ERROR. THE OPERATOR MAY HAVE CONNECTED VACUUM REGULATOR TO WALL OXYGEN OUTLET. HOWEVER, IT HAS YET TO BE DETERMINED WHY THE GAS DID NOT ESCAPE THROUGH THE ESOPHAGUS AND ORAL ROUTE. THE PT SUSTAINED A CARDIAC ARREST AFTER THE POSSIBLE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA OXYGEN OUTLET "DIAMOND" FLUSH TYPE OUTLET, RECESSED CCN MEDAES INC. (FORMERLY OHMEDA MEDICAL ENGINEERING SYSTEMS) DIAMOND N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death 1) SALEM SUMP| 2) VACUUM REGULATOR(S).