BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONY LED 585

    MDR report key: 3832261 · Received March 27, 2014

    Report

    Report Number
    1043572-2014-00014
    Date Received
    March 27, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 28, 2014
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY AND WAS INFORMED THAT THE PLASTIC COVER DETACHED FROM THE SUSPENSION COMPONENT OF THE LIGHT AND FELL UPON A STERILE MAYO STAND HOLDING INSTRUMENTS AND SUPPLIES. THE COVER DID NOT FALL ON THE PT OR WITHIN THE INCISION SITE. THE AFFECTED STAND, INSTRUMENTS AND SUPPLIES WERE IMMEDIATELY REMOVED. THE STERIS TECHNICIAN INSPECTED THE LIGHTING SYSTEM AND OBSERVED EVIDENCE OF IMPACT DAMAGE. AFTER SPEAKING WITH THE FACILITY'S BIOMED DEPT, THE TECHNICIAN WAS INFORMED THE IMPACT DAMAGE WAS THE RESULT OF USER NEGLIGENCE. THE BIOMED STATED THAT OFTEN TIMES THE LIGHT COLLIDES WITH OTHER EQUIPMENT LOCATED IN THE ROOM CAUSING THE DAMAGE NOTE. THE TECHNICIAN REPLACED THE BROKEN ELBOW COVER AND EVALUATED ALL THE OTHER LIGHTING SYSTEMS AT THE USER FACILITY. THE TECHNICIAN'S INSPECTION REVEALED THAT OTHER LIGHTING SYSTEMS EVIDENCED SIMILAR IMPACT DAMAGE ALONG WITH RUSTING. THE BIOMED DEPT STATED THEY HAD BEEN CLEANING THE SURGICAL LIGHTS WITH CHEMICALS WHICH WERE FOUND TO BE CAUSING THE RUSTING OF THE SURGICAL LIGHTS. THE FACILITY BIOMED THEY HAVE SINCE SWITCHED TO USING THE CORRECT CLEANING PRODUCTS. THE STERIS TECHNICIAN IS WORKING WITH THE USER FACILITY IN ORDER TO REPLACE THE COVERS ON ALL OF THE LIGHTING SYSTEMS INSTALLED AT THE USER FACILITY. IN ADDITION, THE STERIS TECHNICIAN ADVISED THE CUSTOMER TO USE CAUTION WHEN OPERATING THE SURGICAL LIGHTS TO AVOID ANY FURTHER IMPACT DAMAGE. THE LIGHTING SYSTEM WAS INSTALLED IN JULY OF 2010 AND IS NOT UNDER STERIS WARRANTY OR SERVICE CONTRACT. THE RECOMMENDED INTERVAL FOR PM'S IS A MINIMUM YEARLY BASIS AND SHOULD BE INCREASED WITH LIGHT USAGE AS NEEDED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A PLASTIC ELBOW COVER DETACHED FROM THE SUSPENSION COMPONENT OF A STERIS HARMONY LED585 SURGICAL LIGHTING SYSTEM DURING A PROCEDURE. NO INJURIES WERE REPORTED. A PROCEDURAL DELAY WAS REPORTED AS THE HOSPITAL REMOVED THE ITEMS AFFECTED BY THE FALLEN COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179450 HARMONY LED 585 SURGICAL LIGHT, PRODUCT CODE: FSY FSY STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1