BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONY 585 LED

    MDR report key: 2993258 · Received March 7, 2013

    Report

    Report Number
    1043572-2013-00018
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE LIGHT AND FOUND THAT THE BRAKE SCREW WAS LOOSE AND THE PIVOT SHAFT IT SCREWS INTO. THE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED EVENT; CONNECT POINT ARM DRIFTING DOWN. THE TECHNICIAN SECURED THE SHAFT AND TIGHTENED THE BRAKE SCREW. THE UNIT IS NOT UNDER STERIS SERVICE CONTRACT AND IS SERVICED AND MAINTAINED BY THE USER FACILITY. THE STERIS TECHNICIAN DISCUSSED WITH THE HOSPITAL'S BIOMEDICAL DEPARTMENT THE IMPORTANCE OF REGULAR PM INSPECTION. A REVIEW OF THE PM SCHEDULE IN THE OPERATOR MANUAL SHOWS THAT THE HARMONY CONNECT POINT SHOULD BE INSPECTED AT A MINIMUM OF EVERY 6 MONTHS AND SHOULD BE INCREASED WITH INCREASED USAGE. STERIS IS GOING TO PROVIDE THE USER FACILITY A QUOTE FOR A PM CONTRACT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS MOVING THE MONITOR ARM ON THE HARMONY LIGHT WHEN THE CONNECT POINT ARM DROPPED HITTING HER IN THE LEFT EYE. THE EMPLOYEE SUSTAINED A BLACK EYE AND STATED SHE HAD A HEADACHE. SHE WAS CHECKED AT THE HOSPITAL WHEN THE EVENT OCCURRED BUT RETURNED TO WORK. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS/CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97728 HARMONY 585 LED SURGICAL LIGHT FSY STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1