BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2161118 · Received June 17, 2011

    Report

    Report Number
    2028159-2011-00679
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE CPU BATTERY TO ADDRESS THE SYSTEM ADVISORY "CPU BATTERY SHOULD BE REPLACED." THE SYSTEM EVENT LOG WAS REVIEWED AND THE MESSAGE "VITRECTOMY NOT AVAILABLE" WAS FOUND. THE COMPANY REPRESENTATIVE REPLACED THE PNEUMATIC CONTROLLER PRINTED CIRCUIT BOARD (PCB) AND CAN CABLE FOR DIAGNOSTIC PURPOSES. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. THE PNEUMATIC CONTROLLER PCB AND CAN CABLE ARE BEING RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED WHILE SETTING UP FOR AN UNPLANNED VITRECTOMY SURGERY, THE VITRECTOMY EQUIPMENT WAS NOT RECOGNIZED BY THE SYSTEM. THE NURSE REPORTS THE VITRECTOMY WAS BEING DONE DUE TO A "DIFFICULT CATARACT" AND THAT IT WAS NOT THE FAULT OF ANY EQUIPMENT. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE WITH NO HARM TO THE PATIENT. THERE WAS A 10 MINUTE DELAY REPORTED.

    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