BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARKON

    MDR report key: 7613509 · Received June 18, 2018

    Report

    Report Number
    MW5077931
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    June 4, 2018
    Report Date
    June 14, 2018
    Manufacturer
    SPACELAB HEALTHCARE INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA MACHINE STOPPED WORKING IN MIDDLE OF CASE IN OPERATING ROOM. EVIDENTLY THIS IS A KNOWN PROBLEM WITH THIS MACHINE PER SPACELABS WITH NO KNOWN FIX. THEIR INVESTIGATION HAS PRODUCED NO ROOT CAUSE ALTHOUGH IT IS HAPPENING ALL OVER THE NATION. THERE IS A "FIX" PLANNED SOON WITH NO GUARANTEES OF SUCCESS. THEY HAVE PROVIDED US WITH A "WORKAROUND" WHEN IT OCCURS WHICH IN THE CURRENT USERS GUIDE. WE HAVE THIS GUIDE POSTED IN ALL OPERATING ROOMS THAT CURRENTLY USE THIS PRODUCT. OUR MEETING WITH SPACELAB'S VICE PRESIDENTS TODAY AT OUR FACILITY LED US TO THE DECISION TO REPLACE THESE MACHINES WITH A MACHINE FROM ANOTHER MANUFACTURER. SPACELAB INFORMED ME THAT THEY HAVE SELF REPORTED THIS ISSUE WITH THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451504 ARKON ANESTHESIA MACHINE BSZ SPACELAB HEALTHCARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention