BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3102334 · Received April 30, 2013

    Report

    Report Number
    2028159-2013-00757
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    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
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY TECHNICAL SUPPORT SPECIALIST (TSS) TO ASSIST WITH TROUBLESHOOTING THE LOST POWER DURING A PROCEDURE. THE TSS ADVISED THE CUSTOMER TO CHECK THE EVENT LOG, WHICH REVEALED THAT A SYSTEM MESSAGE (SM) (LOST AC) OCCURRED TWICE. THE TSS TOLD THE CUSTOMER TO CHECK THE POWER CORD CONNECTION AND WAS INFORMED BY THE CUSTOMER THAT THE POWER CORD WAS CONNECTED TO AN EXTENSION CORD. THE CUSTOMER OBSERVED THIS WAS MOST LIKELY THE CAUSE OF THE POWER LOSS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER REVEALED THAT WHEN THE SYSTEM WAS MOVED SLIGHTLY THE POWER CORD CAME OUT OF THE EXTENSION POWER CORD. THE EVENT WAS RESOLVED WHEN THE CUSTOMER PLUGGED THE POWER CORD INT THE WALL OUTLET DIRECTLY. THE SYSTEM OPERATOR'S MANUAL INCLUDES A STATEMENT TO PLUG THE MAIN POWER CORD INTO A SUITABLE WALL OUTLET AND ALSO HAS A CAUTION STATEMENT TO NOT USE MULTIPLE PORTABLE OUTLETS WITH THIS SYSTEM. THE FACILITY DID NOT REQUEST SERVICE. 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. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO PLUGGING THE SYSTEM POWER CORD INTO AN EXTENSION CORD AND WITH SLIGHT MOVEMENT OF THE SYSTEM, THE POWER CORD WOULD DISCONNECT. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED THE UNIT LOST POWER DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE ENGINEER REPORTED THAT HE BELIEVES THE PROBLEM WAS CAUSED BY A POOR CONNECTION BETWEEN THE POWER CORD OF THE SYSTEM AND THE EXTENSION CORD THAT WAS BEING USED. THE MACHINE WAS MOVED SLIGHTLY DURING SURGERY AND THE POWER CORD CAME OUT OF THE EXTENSION CORD CAUSING THE SYSTEM TO SHUT DOWN. THERE WAS A SEVEN MINUTE DELAY TO REBOOT AS THEY ATTEMPTED THE REBOOT FOUR TIMES. THE ISSUE WAS RESOLVED WHEN THE NURSE PLUGGED THE POWER CORD OF THE SYSTEM DIRECTLY INTO THE WALL INSTEAD OF AN EXTENSION CORD. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188219 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1