BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 1834411 · Received September 10, 2010

    Report

    Report Number
    2028159-2010-01726
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    MPA
    PMA / PMN Number
    K951627
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY WAS ADVISED BY TECHNICAL SERVICES TO CLEAN THE FILTER OF THE FAN ON THE UNIT. AFTER THIS WAS DONE, THE MACHINE DID NOT DISPLAY ANY ERRORS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "TURNED OFF DURING PROCEDURE" (LOSS OF POWER); "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). A NURSE REPORTED THE LIGHT SOURCE TURNED OFF DURING A PROCEDURE. IT WAS ALSO REPORTED THAT A SYSTEM MESSAGE WAS DISPLAYED. THE PROCEDURE WAS COMPLETED WITH A LIGHT PROVIDED BY A SECOND UNIT. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM ENDOILLUMINATOR MPA ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1