BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOLARMAXX 300

    MDR report key: 1659906 · Received April 6, 2010

    Report

    Report Number
    1035968-2010-00001
    Event Type
    Other
    Date Received
    April 6, 2010
    Date of Event
    March 7, 2010
    Report Date
    March 29, 2010
    Manufacturer
    SUNOPTICS
    Product Code
    FSS
    PMA / PMN Number
    K961074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL'S IMPRESSION: THE POWER SUPPLY FAILED, CAPACITOR BLEW UP, BURNT ELECTRONICS SMELL AND SMOKE CAUSED UN-DUE STRESS, TIME DELAY AND CONCERNS. THEY HAVE SENT US A REPLACEMENT DEVICE WHILE THEY INVESTIGATE THE OTHER. YOU CANNOT PURCHASE A POWER SUPPLY AS A SEPARATE ITEM. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). THIS INCIDENT APPEARS TO BE A RANDOM COMPONENT FAILURE OF THE POWER SUPPLY / LIGHT SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLARMAXX 300 LIGHTSOURCE, XENON FSS SUNOPTICS SOLAR MAXX 300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other