BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONY SURGICAL LIGHT (LED)

    MDR report key: 3050987 · Received April 10, 2013

    Report

    Report Number
    1043572-2013-00034
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGICAL LIGHT WALL CONTROLLER SUBJECT OF THIS REPORTED EVENT WAS RETURNED TO STERIS ENGINEERING FOR EVALUATION. RESULTS OF THE EVALUATION IDENTIFIED A SHORT IN THE CONTROLLER CAUSED BY A LOOSE TERMINAL SCREW. AS REPORTED IN OUR INITIAL REPORT, HAD THE SYSTEM BEEN PROPERLY EQUIPPED BY THE USER FACILITY WITH A DEDICATED CIRCUIT BREAKER, THE BREAKER WOULD HAVE TRIPPED AND SHUT THE POWER OFF. A REVIEW OF COMPLAINT RECORDS INDICATE THAT THIS IS AN ISOLATED EVENT.

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN INSPECTED THE LIGHT AND THE WALL CONTROLLER, AND FOUND DAMAGE LIMITED TO THE #2 POWER SUPPLY. CHARRING OF THE 120VAC SUPPLY WIRES AND INTERNAL COMPONENTS WAS NOTED. THE TECHNICIAN NOTED THAT THE CONTROLLER WAS CONNECTED TO THE SAME CIRCUIT BREAKER AS TWO OTHER WALL CONTROL UNITS AND LIGHTING SYSTEMS. THE STERIS DISTRICT SERVICE MANAGER STATED THAT STERIS RECOMMENDS THAT EACH INDIVIDUAL LIGHT SYSTEM HAVE A DEDICATED BREAKER. STERIS CANNOT SPEAK TO THE CAUSE OF THE FAILURE OF THE BREAKER TO TRIP, BECAUSE IT IS NOT A PIECE OF STERIS EQUIPMENT. STERIS RECOMMENDED THAT A LICENSED ELECTRICIAN REVIEW THE CIRCUIT, AND ALSO THAT DEDICATED CIRCUITS BE INSTALLED FOR EACH LIGHT. INSTALLATION OF UTILITIES IS THE RESPONSIBILITY OF THE HOSPITAL, AND IS TO BE IN ACCORDANCE WITH NATIONAL AND LOCAL CODES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A HARMONY SURGICAL LIGHT WALL CONTROLLER CAUGHT FIRE AT THE CONCLUSION OF A SURGICAL CASE. THE PROCEDURE HAD BEEN COMPLETED AND THE PATIENT WAS BEING REMOVED FROM THE ROOM AND RELOCATED TO RECOVERY PRIOR TO THE EVENT. THE FACILITY REPORTED THAT STAFF HEARD AN ELECTRICAL ARCING SOUND COMING FROM THE CONTROLLER. UPON CLOSER INSPECTION OF THE CONTROLLER, SPARKS AND BLACK SMOKE CAME OUT OF THE UNIT. SUBSEQUENTLY, FLAMES WERE OBSERVED. A DRY CHEMICAL EXTINGUISHER WAS SPRAYED ON THE CONTROLLER. THE FIRE DEPARTMENT WAS DISPATCHED TO THE SITE, AND REMAINED ON-SITE UNTIL THE CONTROLLER WAS REMOVED FROM THE WALL. NO INJURIES WERE REPORTED. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151935 HARMONY SURGICAL LIGHT (LED) SURGICAL LIGHT FSY STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1