BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENON LIGHT SOURCE 300 WATT W/

    MDR report key: 7037650 · Received November 16, 2017

    Report

    Report Number
    2523190-2017-00127
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    September 19, 2017
    Report Date
    October 24, 2017
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KOG
    PMA / PMN Number
    K992006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 11/14/2017 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - COMPLAINT IS UNCONFIRMED; THIS IS DUE TO THE PRODUCT NOT BEING RETURNED FOR REVIEW. COMPLAINT WILL BE REOPENED IF PRODUCT IS RECEIVED. DEVICE HISTORY EVALUATION - DHR REVIEW: NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED INVESTIGATION ON DECEMBER 1, 2017: FAILURE ANALYSIS - THE MANUFACTURING DATE OF THIS UNIT IS 2003. A VISUAL INSPECTION OF THE EXTERIOR FOUND THE UNIT WITH MULTIPLE SCRATCHES AND LABELING STATING ¿10/26/16 JMS RETIRED HOLD 4TRADE IN/PARTS¿. THE FUSE HOLDER AND FUSES WERE NOT INSTALLED. A VISUAL INSPECTION OF THE INTERIOR FOUND THE FUSE HOLDER AND TWO BLOWN (OPEN) FUSES LAYING INSIDE THE UNIT. THE POWER SUPPLY HAD ¿BAD¿ WRITTEN ON IT AND A DAMAGED COMPONENT (ELECTROLYTIC CAPACITOR) ON LOCATION RT104. NO OTHER SIGNS OF DAMAGE (HEAT OR OTHERWISE) WAS OBSERVED. WHEN THE ELECTROLYTIC CAPACITOR FAILED, THIS CAUSED THE UNIT TO SMOKE AND WILL HAVE A STRONG ODOR. CAPACITORS CAN FAIL FROM MULTIPLE REASONS (AGE, POWER SURGES) AND THE FAILURE MODE CAN DIFFER, BUT A BLOWN CAPACITOR IS NOT UNHEARD OF AND WILL SMOKE WHEN IT FAILS. WHEN THE FAILURE DOES OCCUR, THE FUSES WILL OPEN AND CUT CURRENT TO THE UNIT AND PREVENT ANY FURTHER DAMAGE. THE OPEN FUSES INSIDE THE UNIT INDICATE THE SYSTEM PERFORMED AS DESIGNED IN THE EVENT OF SUCH FAILURE. THE COMPLAINT CAN BE CONFIRMED; THE ROOT CAUSE WAS A COMPONENT (CAPACITOR) FAILURE ON THE POWER SUPPLY.

    Description of Event or Problem · 1

    USER FACILITY REPORT # (B)(4) FROM (B)(6). STRONG ODOR OF MELTING OR BURNING PLASTIC WAS NOTICED BY OPERATIVE STAFF DURING PROCEDURE. SMELL WAS DETERMINED TO BE ISOLATED TO THE CV OR ROOM. LIGHT SOURCE WAS NOTED TO BE EXCEPTIONALLY HOT TO TOUCH THE TOUCH AND SCENT WAS EXCEEDINGLY STRONG AROUND UNIT. UNIT WAS UNPLUGGED AND REMOVED FROM ROOM, BIOMED NOTIFIED. REPLACEMENT LIGHT SOURCE BROUGHT INTO ROOM, CASE CONTINUED AS PER THE NORM. BIOMED TECHNICIAN FOUND A DEFECTIVE ELECTRONIC COMPONENT (ELECTROLYTIC CAPACITOR) IN THE POWER SUPPLY SECTION. CAPACITOR WAS REPLACED. CHECKED OPERATION OF LIGHT SOURCE FOR MORE THAN 2 HOURS. RETURNED LIGHT SOURCE TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819141 XENON LIGHT SOURCE 300 WATT W/ 300W LS KOG INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1