BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDS BOOMS SYSTEM

    MDR report key: 2933217 · Received January 11, 2013

    Report

    Report Number
    2031963-2013-90007
    Event Type
    Other
    Date Received
    January 11, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT NUMBER: THE REASON FOR SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS. THERE WAS PT INVOLVEMENT REPORTED, HOWEVER THE HOSPITAL DECLINED TO PROVIDE ANY PT DATA. THE CATALOG NUMBER PROVIDED IS FOR THE 750 SERVICE HEAD WHICH IS A PART OF THE EDS BOOM SYSTEM. IT WAS REPORTED THAT THE CUSTOMER BROUGHT A MOBILE DOCUMENTATION STATION INTO THE ROOM AND THAT WHILE A PT WAS ON THE TABLE THEY SWUNG THE BOOM ARM INTO THE DOCUMENTATION STATION WHICH CAUSED THE DOCUMENTATION STATION TO ALLEGEDLY FALL AND COME INTO CONTACT WITH THE PT. IT WAS FURTHER REPORTED THAT ALL THE BRAKES AND STOPS ON THE BOOM ARM WERE FUNCTIONING PROPERLY. THERE WAS NO NON-CONFORMANCE FOUND WITH ANY STRYKER PRODUCT AND THE ROOT CAUSE OF THIS EVENT CAN BE ATTRIBUTED TO USER ERROR OF THE BOOM ARM.

    Description of Event or Problem · 1

    (B)(4): IT WAS REPORTED THAT DURING A PROCEDURE IN THE CYSTO ROOM, THE USER MOVED AN ARTICULATING EQUIPMENT BOOM ARM INTO A ROLLING DOCUMENTATION STATION, IMPACTING THE DOCUMENTATION STATION AND ALLEGEDLY CAUSING IT TO TIP OVER AND COME INTO CONTACT WITH A PT. THERE WAS NO REPORTED MALFUNCTION OF A STRYKER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18233 EDS BOOMS SYSTEM BRY STRYKER COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention