BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM LED, SURGICAL LIGHT, CAMERA READY

    MDR report key: 1234059 · Received November 4, 2008

    Report

    Report Number
    2031963-2008-00021
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    STRYKER COMMUNICATIONS .
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION LISTED AS NA SINCE NO PATIENT WAS INVOLVED. DEVICE MANUFACTURED DATE WILL BE SUBMITTED IN THE SUPPLEMENTAL REPORT. RETURNED PRODUCT WAS EVALUATED VIA VISUAL EXAMINATION. THE INITIAL INVESTIGATION BY (B)(6) INDICATES THAT INTERNAL CIRCUIT BOARD FAILURE MAY HAVE OCCURRED. PER (B)(6), "IT APPEARS THAT THE TERMINAL BLOCK ON THE MASTER MOTHERBOARD FAILED AND SHORTED INTERNALLY." THE RESULT CODE AND CONCLUSION CODES WERE LISTED AS "OTHER" SINCE THE LIGHT HEAD HAS BEEN RETURNED TO THE CONTRACT MANUFACTURER FOR FAILURE MODE ANALYSIS TO THE COMPONENT LEVEL. A SUPPLEMENTAL REPORT WILL BE FILED DESCRIBING THE RESULTS OF THIS INVESTIGATION ONCE THIS INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    PER CUSTOMER: OR6 LED LIGHT 1 IS NOT POWERING ON. THE ACCOUNT STATES THAT THERE WAS SMOKE COMING FROM THE LIGHT. PER CUSTOMER, THERE WAS A REPORT OF THE LIGHT CATCHING ON FIRE. THE CUSTOMER STATED THAT THE ISSUE WAS DISCOVERED DURING THE PREPPING OF THE ROOM. THE CUSTOMER STATES THAT NO PATIENTS WERE ADVERSELY AFFECTED. THE CUSTOMER STATES NO ABNORMAL CONDITIONS EXISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISUM LED, SURGICAL LIGHT, CAMERA READY SURGICAL LIGHT FSY STRYKER COMMUNICATIONS . NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK