BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIS

    MDR report key: 2971597 · Received January 17, 2013

    Report

    Report Number
    2971597
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE POWER OUTLETS STOPPED WORKING; UPON INSPECTION FOUND THAT THE WIRES WERE CUT THROUGH AND BARE INSIDE THE BOOM HOUSING NEXT TO THE OXYGEN AND AIR LINES WHICH ALSO SHOW SIGNS OF WEAR. THE FLEXIBLE CONDUIT WAS CUT THROUGH AND THE WIRING WAS ENTWINED AGAINST A METAL STOP. THE BOOM WAS FOUND TO BE MISSING A WEAR BUSHING THAT WOULD PROTECT THE WIRING AND THE GAS LINES. THE DEVICE WAS NOT BEING USED ON A PATIENT AT THE TIME OF THE EVENT.======================MANUFACTURER RESPONSE FOR STRYKER BOOM, OSC-400 BOOM (PER SITE REPORTER).======================THE MANUFACTURE FEELS IT IS AN ENGINEERING DEFECT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?POWER EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27515 FLEXIS CABINET, TABLE AND TRAY, ANESTHESIA BRY STRYKER COMMUNICATIONS OSC-400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *