BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONY LED585 SURGICAL LIGHT

    MDR report key: 3971585 · Received July 31, 2014

    Report

    Report Number
    1043572-2014-00066
    Date Received
    July 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 31, 2014
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE LIGHTING SYSTEM AND FOUND PAINT DAMAGE ON THE UNDERSIDE OF THE CONNECTPOINT ARM AND CENTER POST. IN ADDITION, THE TECHNICIAN OBSERVED PAINT CHIPPING OF THE LIGHTHEAD WHERE IS CONNECTS TO THE SPRING ARM. WHILE ONSITE THE TECHNICIAN ADVISED USER FACILITY PERSONNEL TO NOT BUMP THE LIGHTHEAD. THE OPERATOR MANUAL STATES (PG.1-3), "CAUTION-POSSIBLE EQUIPMENT DAMAGE HAZARD: DO NOT BUMP LIGHTHEADS INTO WALLS OR OTHER EQUIPMENT. ALSO USE HANDLES WHEN POSITIONING LIGHTHEAD DURING SURGICAL PROCEDURES, OR WHEN CLEANING OR SERVICING THE LIGHTING SYSTEM." THE SURGICAL LIGHT IS NOT SERVICED OR MAINTAINED BY STERIS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE PAINT CHIPS FROM THEIR SURGICAL LIGHT FELL ONTO A PATIENT. THE USER FACILITY WOULD NOT PROVIDE ADDITIONAL EVENT INFORMATION HOWEVER, NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447807 HARMONY LED585 SURGICAL LIGHT SURGICAL LIGHT FSY STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other