BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1781242 · Received July 29, 2010

    Report

    Report Number
    2028159-2010-01341
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 2010
    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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. ALL CABLE CONNECTIONS WERE CHECKED AND ALL CIRCUIT BOARDS WERE RESEATED. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. QUALITY ASSURANCE WILL MONITOR RELATED COMPLAINTS AND WILL TAKE ACTION FOR FURTHER OCCURRENCES AS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT HARM/IMPACT" (NO CONSEQUENCES OR IMPACT TO THE PATIENT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE INDICATING A COMMUNICATION ERROR." (DEVICE DISPLAYS ERROR MESSAGE); "EXCHANGED SYSTEM" (NO CODE AVAILABLE). A NURSE REPORTED A COMMUNICATION ERROR UPON START-UP OF THE SYSTEM. THE SYSTEM WAS EXCHANGED TO PERFORM CASES. NO ADDITIONAL INFORMATION WAS GIVEN. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1