BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER CHROMOPHASE

    MDR report key: 15293716 · Received August 24, 2022

    Report

    Report Number
    MW5111715
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    August 19, 2022
    Report Date
    August 23, 2022
    Manufacturer
    STRYKER COMMUNICATIONS, INC.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    EXAM LIGHT STRYKER F628 CAME LOOSE AND FELL TO FLOOR FROM SPRING ARM IN OUR OPERATING ROOM #3. NO PATIENT IN ROOM AT THE TIME. KEEPER RING AND SET SCREW HAD COME LOOSE CAUSING FALL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343419 STRYKER CHROMOPHASE LIGHT, SURGICAL, CEILING MOUNTED FSY STRYKER COMMUNICATIONS, INC. F628

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown