BEUDAMED
    FDA Adverse Event Summary report: N

    DUAL HARMONY LA SURGICAL LIGHT

    MDR report key: 3202851 · Received July 2, 2013

    Report

    Report Number
    1043572-2013-00072
    Date Received
    July 2, 2013
    Date of Event
    May 9, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT REMAINS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    AN AMCO ENGINEER INSPECTED THE WALL CONTROL AND FOUND THE CONDENSER IN THE POWER SUPPLY HAD BLOWN OUT. THE REPORTED SMOKE WAS AN OUT GASSING OF THE ELECTROLYTE INSIDE THE CAPACITOR. THERE WAS NO FIRE OR FLAME AS A RESULT OF THE CAPACITOR FAILURE. FURTHERMORE, THE CAPACITOR IS HOUSED INSIDE THE POWER SUPPLY WHICH IS LOCATED IN THE WALL CONTROL. THE POWER SUPPLY BOX ASSEMBLY WAS SENT BACK TO STERIS QUALITY FOR EVALUATION. EVALUATION RESULTS INDICATED THAT THE MALFUNCTION OF THE CONDENSER WITHIN THE POWER SUPPLY BOX ASSEMBLY COULD BE ATTRIBUTED TO OVERHEATING CAUSED BY A POWER FLUCTUATION AT THE USER FACILITY. AMCO IS AWARE OF THE AIRFLOW REQUIREMENTS FOR THE CONTROLLER AND POWER SUPPLY. THE AMCO ENGINEER REPLACED THE POWER SUPPLY BOX ASSEMBLY AND CONFIRMED IT TO BE OPERATIONAL; NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE WALL CONTROL EMITTED SMOKE AFTER A PATIENT PROCEDURE. NO INJURIES TO HOSPITAL STAFF OR PATIENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302109 DUAL HARMONY LA SURGICAL LIGHT SURGICAL LIGHT FTD STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1