BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL II

    MDR report key: 3190656 · Received June 21, 2013

    Report

    Report Number
    2028159-2013-01200
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE POWER SUPPLY. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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 CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SYSTEM TURNED OFF ON ITS OWN DURING A PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282848 UNIVERSAL II PHACOEMULSIFICATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER UNIV II NA

    Patients

    Seq Age Sex Outcome Treatment
    1