BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2150679 · Received June 22, 2011

    Report

    Report Number
    2028159-2011-00714
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND A POWER ON/OFF ISSUE. THE HOST MODULE WAS REPLACED. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED ADN MET ALL PRODUCT SPECIFICATIONS. NO SAMPLE RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE EQUIPMENT WOULDN'T TURN. NO SYSTEM MESSAGES WERE DISPLAYED. THE EVENT OCCURRED PRIOR TO SURGERY; HOWEVER, TWO PTS HAD RECEIVED LOCAL ANESTHETIC BLOCKS AND SEDATION IN PREPARATION FOR SURGERY. THEIR CASES WERE CANCELLED. NO PT IDENTIFIERS WERE PROVIDED, AND NO HARM TO EITHER PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1