BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONY LC SURGICAL LIGHT

    MDR report key: 1971241 · Received January 26, 2011

    Report

    Report Number
    1043572-2011-00007
    Date Received
    January 26, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 26, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FTD
    PMA / PMN Number
    KO13242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE LIGHTHEAD AND COULD NOT DUPLICATE THE EVENT. THE TECHNICIAN FOUND THAT BOTH THE PRIMARY AND BACKUP LAMPS IN THE LIGHTHEAD WERE NON-STERIS LAMPS, AND THAT THERE WAS A CRACK IN THE LIGHTHEAD SOCKET. THE TECHNICIAN REPLACED THE LIGHTHEAD SOCKET, REPLACED THE LAMPS WITH STERIS LAMPS, TESTED THE LIGHTHEAD AND PLACED IT BACK INTO SERVICE; NO FURTHER ISSUES WITH THIS LIGHTHEAD HAVE BEEN REPORTED. THE CAUSE OF THIS EVENT IS LIKELY DUE TO THE USE OF NON-STERIS LAMPS WHICH CAUSED THE LIGHTHEAD TO OVERHEAT AND STOP WORKING. THE OPERATOR MANUAL CONTAINS A WARNING THAT STATES "USE ONLY STERIS REPLACEMENT LAMPS IN THIS LIGHTING FIXTURE. USE OF LAMPS OTHER THAN THOSE PROVIDED BY STERIS MAY DAMAGE THIS EQUIPMENT." THE LIGHTHEAD IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED BY THE FACILITY BIOMEDICAL DEPARTMENT. STERIS HAS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE LIGHTHEAD AND IS AWAITING A RESPONSE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE SURGICAL LIGHTHEAD STOPPED WORKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH MINIMAL DELAY AS HOSPITAL STAFF UTILIZED ANOTHER LIGHTHEAD PRESENT IN THE OPERATING ROOM. NO INJURIES WERE REPORTED TO HOSPITAL STAFF OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONY LC SURGICAL LIGHT SURGICAL LIGHT FTD STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1