BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM LED SURGICAL LIGHT

    MDR report key: 2833295 · Received October 26, 2012

    Report

    Report Number
    2031963-2012-00150
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE, NO PT DATA EXISTS. THE CATALOG NUMBER PROVIDED IS FOR THE POWER SUPPLY BOX WHICH IS THE COMPONENT IDENTIFIED AS ALLEGEDLY MALFUNCTIONING. EVAL SUMMARY - IT WAS REPORTED THAT BOTH SURGICAL LIGHTS IN THE OPERATING ROOM WOULD INTERMITTENTLY TURN OFF. A STRYKER FIELD SERVICE REP EVALUATED THE SURGICAL LIGHTS AT THE USER FACILITY AND COULD NOT DUPLICATE THE REPORTED ISSUE. HOWEVER, EVAL OF THE POWER SUPPLY BOX ERROR CODES SHOWED THAT SOME INTERRUPTIONS IN FUNCTIONING HAD BEEN RECORDED BY THE DEVICE. AS THE REPORTED ISSUE COULD NOT BE REPLICATED, THE ROOT CAUSE OF THE LIGHTS INTERMITTENTLY SHUTTING OFF COULD NOT BE IDENTIFIED AND NO MALFUNCTION OF THE LIGHTS COULD BE CONFIRMED.

    Description of Event or Problem · 1

    (B)(4): IT WAS REPORTED THAT BOTH SURGICAL LIGHTS WOULD INTERMITTENTLY TURN OFF. THIS WAS OBSERVED DURING PREPARATION OF THE ROOM. THERE WAS NO REPORTED PT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISUM LED SURGICAL LIGHT FSY STRYKER COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1