BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 1840790 · Received September 17, 2010

    Report

    Report Number
    2028159-2010-01778
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. THE REPORTED SYSTEM WAS SERVICED BY THE FACILITY'S BIOMEDICAL DEPARTMENT. PER THE FACILITY, THE SYSTEM'S FILTER WAS FOUND TO BE DIRTY CAUSING THE UNIT TO OVERHEAT. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SCREEN WENT BLANK" (NO DISPLAY OR DISPLAY FAILURE). A NURSE REPORTED DURING THE CASE THE SCREEN WENT BLANK. THE SYSTEM WAS UNPLUGGED, TURNED BACK ON, AND THE CASE WAS COMPLETED. A FIVE MINUTE DELAY WAS EXPERIENCED WHILE THE SYSTEM WAS REBOOTED. THERE WAS NO PT HARM REPORTED. ADDITIONAL INFORMATION WAS REC'D FROM THE NURSE REPORTING THE BIOMEDICAL DEPARTMENT SERVICED THIS UNIT AND DISCOVERED THAT THE FILTER WAS DIRTY WHICH CAUSED THE UNIT TO OVERHEAT.

    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