BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHROMOPHARE

    MDR report key: 3733215 · Received March 28, 2014

    Report

    Report Number
    1220685-2014-00003
    Event Type
    Other
    Date Received
    March 28, 2014
    Report Date
    February 17, 2014
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 USER WAS MADE AWARE OF THE INDICATIONS FOR USE.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT AN (B)(6) OLD PATIENT REC'D BURNS AFTER A SURGICAL PROCEDURE. TWO LAMPHEADS WERE REPORTED TO HAVE BEEN ILLUMINATING THE PATIENT DURING THE PROCEDURE. THE DATE OF THE EVENT, THE INTENSITY OF EACH LAMPHEAD, AND DURATION OF THE PROCEDURE WERE NOT REPORTED. THE LIGHTS WERE EVALUATED BY A BERCHTOLD CORP. SERVICE TECHNICIAN AT THE LOCATION WHERE THE INCIDENT OCCURRED. THE LAMPHEADS WERE INSPECTED AND THE LIGHT INTENSITY IN LUX WAS MEASURED FOR EACH LAMPHEAD. THE SPECIFICATION FOR INTENSITY IS 160KLUX. THE INTENSITY FOR LAMPHEAD S/N (B)(4) (THIS MDR) WAS MEASURED TO BE 148 KLUX. THE UV LEVELS A, B, C WERE MEASURED TO BE 7.3W/M2. THE INTENSITY FOR LAMPHEAD S/N (B)(4)(MDR 1220685-2014-00002) WAS MEASURED TO BE 154KLUX. THE UV LEVELS A, B, C WERE MEASURE TO BE 8.6W/M2. THE MAXIMUM ALLOWED BY THE SURGICAL LIGHT STANDARD IS 10W/M2. AN INSPECTION OF THE LIGHTS, ELECTRONICS, FILTER GLASS AND CONTROL BOX WAS CONDUCTED AND ALL WERE FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184909 CHROMOPHARE SURGICAL LIGHT FSY BERCHTOLD CORP. E655

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Other