BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1772298 · Received July 23, 2010

    Report

    Report Number
    2028159-2010-01276
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND REPLACED THE IV POLE CONTROLLER PCB (PRINTED CIRCUIT BOARD). THE SOFTWARE WAS UPDATED. THE SYSTEM WAS TESTED AND FOUND TO MEET ALL PRODUCT SPECIFICATIONS. NO SAMPLE WAS RETURNED FOR EVAL AND ROOT CAUSE ANALYSIS. THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED; THERE WERE NO ADD'L SIMILAR COMPLAINTS ASSOCIATED WITH THIS SYSTEM. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO 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 PATIENT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). THE OPERATING ROOM MGR REPORTED THAT THE SYSTEM'S MOTORIZED IV POLE WOULD NOT GO UP OR DOWN DURING SET UP AND A SYSTEM MESSAGE WAS DISPLAYED. A PT HAD ALREADY RECEIVED ANESTHETIC BLOCK, AND THAT PT'S SURGERY WAS ABORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1