BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHROMOPHARE

    MDR report key: 2281262 · Received September 30, 2011

    Report

    Report Number
    1220685-2011-00005
    Event Type
    Other
    Date Received
    September 30, 2011
    Date of Event
    September 27, 2011
    Report Date
    September 28, 2011
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAMPHEADS WERE INSPECTED AND THE LIGHT INTENSITY IN LUX WAS MEASURED FOR EACH LAMPHEAD. THE SPEC FOR INTENSITY IS 160 KLUX. THE INTENSITY FOR LAMPHEAD S/N (B)(4) WAS MEASURED TO BE 196 KLUX, AND THE INTENSITY FOR LAMPHEAD S/N (B)(4) WAS MEASURED TO BE 153 KLUX. THE INTENSITY FOR EACH LAMPHEAD WAS ADJUSTED TO MEET SPEC. THE OPERATORS MANUAL FOR THIS LIGHT SYSTEM CONTAINS THE FOLLOWING SAFETY STATEMENTS FOR THE OPERATOR: THE OVERLAY OF THE LIGHT FIELDS CAN CAUSE AN INCREASE IN HEAT GENERATION. IN THE CASE OF A COMBINATION LIGHT THE LAMP HOUSINGS ARE POSITIONED SO THAT THE LIGHT FIELDS OF BOTH LIGHTS ARE COINCIDENT, THE OPERATOR SHOULD CONSIDER THE FOLLOWING: THE LIGHT'S ADJUSTMENT TO MAXIMUM ILLUMINATION CAUSES AN INCREASED DESICCATION OF THE TISSUE. THE OPERATORS MANUAL AND THE SERVICE MANUAL SPECIFY THAT MAINTENANCE NEEDS TO BE PERFORMED YEARLY AGAINST A CHECKLIST, AND THE ITEMS ON THE CHECKLIST INCLUDE INTENSITY OF ILLUMINATION AND BULB VOLTAGE. BERCHTOLD DOES NOT HAVE A MAINTENANCE CONTRACT WITH THIS FACILITY AND COULD NOT OBTAIN ANY INFO THAT SUPPORTS THE LIGHTS WERE MAINTAINED IN ACCORDANCE WITH MANUFACTURERS INSTRUCTIONS. THE SAFETY STATEMENTS AND MAINTENANCE REQUIREMENTS WERE BROUGHT TO THE ATTENTION OF THE USERS FOR FUTURE REFERENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PT SUSTAINED BURNS DESCRIBED AS BLISTERED AREAS, AFTER A 1 HOUR LONG HERNIA PROCEDURE. IT WAS ALSO REPORTED THAT THE LIGHT FROM TWO LAMPHEADS AT FULL INTENSITY WERE FOCUSED ON THE SURGICAL AREA AT "ARMS LENGTH" ABOVE THE TABLE, AND THAT BETADINE WAS USED ON THE PT'S SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMOPHARE SURGICAL LIGHT FSY BERCHTOLD CORP. D660

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other