BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE, VISUM LED 2 SURGICAL LIGHT

    MDR report key: 2971680 · Received February 21, 2013

    Report

    Report Number
    0002031963-2013-00005
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE ORIGINAL REPORTED ISSUE FROM THE CUSTOMER WAS FOR HALF OF THE LED PODS IN A VISUM LED SURGICAL LIGHT HEAD WERE NOT POWERING ON. A STRYKER FIELD SERVICE REPRESENTATIVE VISITED THE USER FACILITY AND VERIFIED THE NON-FUNCTIONING SURGICAL LIGHT HEAD. THE SERVICE TECHNICIAN ALSO DISCOVERED EVIDENCE OF BURNING ON THE PRINTED CIRCUIT BOARD WITHIN THE LIGHT HEAD. THE LIGHT HEAD WAS REPLACED. THERE WAS NO REPORT OF SMOKE OR FIRE FROM THE CUSTOMER. THIS WAS ONLY NOTICED BY THE SERVICE TECHNICIAN UPON INSPECTION OF THE LIGHT HEAD AT THE USER FACILITY. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    UPON INSPECTING A SURGICAL LIGHT HEAD AT A USER FACILITY IN WHICH HALF OF THE LED PODS WERE ALLEGEDLY NOT LIGHTING UP, EVIDENCE OF BURNING/CHARRING WAS OBSERVED ON THE PRINTED CIRCUIT BOARD. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76915 PACKAGE, VISUM LED 2 SURGICAL LIGHT VISUM LED SURGICAL LIGHTS FSY STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1