BEUDAMED
    FDA Adverse Event Summary report: N

    DUAL HARMONY LIGHT

    MDR report key: 3832251 · Received January 8, 2014

    Report

    Report Number
    1043572-2014-00001
    Date Received
    January 8, 2014
    Date of Event
    December 9, 2013
    Report Date
    January 8, 2014
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE LIGHT AND FOUND THE KNUCKLE COVER WAS NOT IN PLACE AND THE SPRING ARM HAD SURGICAL TAPE HOLDING THE TWO HALVES OF THE SPRING ARM COVER TOGETHER, INDICATIVE OF MISUSE. THE LIGHT WAS OPERABLE AT THE TIME OF INSPECTION, HOWEVER THE CUSTOMER REPORTED THE LIGHT WAS DRIFTING. THE TECHNICIAN REINSTALLED THE COVER, ADJUSTED EACH OF THE BREAKS TO CORRECT THE DRIFTING AND RETURNED THE LIGHT TO SERVICE. THE SURGICAL LIGHT IS NOT MAINTAINED BY STERIS; THE USER FACILITY IS RESPONSIBLE FOR MAINTAINING THE LIGHT. THE SERVICE TECHNICIAN AND DISTRICT SERVICE MANAGER SPOKE TO THE FACILITY REGARDING THE IMPORTANCE OF PROPERLY MAINTAINING THE SURGICAL LIGHTS AND PROVIDED THEM WITH AN OFFER TO PLACE THE LIGHTS UNDER THE STERIS INSPECTION AND MAINTENANCE PROGRAM; HOWEVER, THE USER FACILITY DECLINED THIS OFFER.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A COVER ON THE ELBOW OF A HARMONY LC DUAL LIGHT FELL ONTO THE FLOOR DURING A PT PROCEDURE; THE STERILE FIELD WAS NOT COMPROMISED. NO INJURIES WERE REPORTED. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12350 DUAL HARMONY LIGHT SURGICAL LIGHT, PRODUCT CODE: FTD FTD STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1