BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDS BOOMS, FLEXIS BOOM SYSTEM

    MDR report key: 2854335 · Received November 28, 2012

    Report

    Report Number
    2031963-2012-00165
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE NO PT DATA EXISTS. THE CATALOG NUMBER PROVIDED IS FOR THE FLEXIS BOOM SYSTEM. THE SERIAL NUMBER PROVIDED IS FOR THE SPECIFIC ARM THAT WAS ALLEGED TO BE INVOLVED IN THIS EVENT. IT WAS REPORTED THAT THE ACCOUNT WAS HAVING DIFFICULTY MOVING THE ARTICULATING BOOM ARM AND THAT THE ARM ALLEGEDLY LOWERED UNEXPECTEDLY REPORTEDLY CAUSING EQUIPMENT TO FALL FROM THE BOOM SHELVES. A STRYKER SERVICE TECHNICIAN VISITED THE SITE AND COULD NOT DUPLICATE THE EVENT, NOR COULD THEY FIND ANY DAMAGE TO OR NON-CONFORMANCE WITH THE BOOM ARM. A MANUFACTURER SERVICE TECHNICIAN WAS ALSO SENT TO EVALUATE THE BOOM ARM AT THE ACCOUNT AND ALSO WAS UNABLE TO DUPLICATE THE EVENT, AND FOUND NOTHING DAMAGED OR NON-CONFORMING IN THE BOOM ARM. THE ARM WAS ARTICULATED SEVERAL TIMES TO ENSURE PROPER FUNCTIONING AND NO ISSUE COULD BE FOUND WITH THE ARM. THERE WAS NO PT INVOLVEMENT AND NO REPORTED ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    STRYKER REFERENCE #(B)(4): IT WAS REPORTED THAT AN ARTICULATING EQUIPMENT BOOM WAS ALLEGEDLY EXPERIENCING DIFFICULTIES WHEN MOVING UP AND DOWN. THE ACCOUNT ATTEMPTED TO LOWER THE BOOM AND THE SERVICE HEAD REPORTEDLY LOWERED A FOOT. WHEN THE SERVICE HEAD REPORTEDLY LOWERED, EQUIPMENT ALLEGEDLY FELL OFF THE SHELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDS BOOMS, FLEXIS BOOM SYSTEM BRY STRYKER COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1