BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARMAXX 300

    MDR report key: 1646383 · Received March 29, 2010

    Report

    Report Number
    1646383
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Date of Event
    March 7, 2010
    Report Date
    March 29, 2010
    Manufacturer
    SUNOPTICS
    Product Code
    FQP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    A SURGEON WAS USING A SUN-OPTIC HEADLIGHT DURING SURGERY. THE LIGHTSOURCE WAS "NOTED TO HAVE WHITE SMOKE BILLOWING OUT OF THE BOX WHEN IT MADE A POPPING SOUND." THE BOX WAS UNPLUGGED AND REMOVED FROM THE ROOM AND TAKEN TO CLINICAL ENGINEERING. THE CASE WAS CONTINUED WITH ANOTHER HEADLIGHT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE POWER SUPPLY FAILED, CAPITOR BLEW UP, BURNT ELECTRONICS SMELL AND SMOKE CAUSED UN-DUE STRESS, TIME DELAY AND CONCERNS.====================== MANUFACTURER RESPONSE ======================THEY HAVE SENT US A REPLACEMENT DEVICE WHILE THEY INVESTIGATE THE OTHER. YOU CANNOT PURCHASE A POWER SUPPLY AS A SEPARATE ITEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *