BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINTI VISION SYSTEM OZIL

    MDR report key: 1880188 · Received October 15, 2010

    Report

    Report Number
    2028159-2010-02021
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ALCON - IRVINE TECHOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY IS ATTEMPTING TO FIND A REPLACEMENT FOOTSWITCH ELSEWHERE. THERE WILL BE NO SAMPLE RETURNING FOR EVALUATION. 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 UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED DURING A CASE THE SYSTEM FROZE. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION, RECEIVED BY THE NURSE, INDICATED SHE WAS UNSURE WHAT STEP OF THE SURGERY THEY WERE IN WHEN THE UNIT FROZE. THERE WAS NO PATIENT IMPACT AND NO CANCELLATIONS, BUT THERE WAS A DELAY DURING THE PROCEDURE OF ABOUT 10 MINUTES WHILE THE SYSTEMS WERE SWITCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINTI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1