BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 4210251 · Received October 21, 2014

    Report

    Report Number
    1825014-2014-00017
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 16, 2014
    Manufacturer
    DDK
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CASE, A SURGICAL LIGHT CEILING COVER CAME APART. IT DID NOT HIT A PT BUT DID DELAY THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670351 SKYTRON SURGICAL LIGHT FSY DDK AUT5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other