BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN COMPACT CONSOLE

    MDR report key: 6662134 · Received June 22, 2017

    Report

    Report Number
    3006695864-2017-00421
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    May 31, 2017
    Report Date
    November 23, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    UDI-DI
    05050474514706
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE MANUFACTURE DATE: 2013. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE ABBOTT MEDICAL OPTICS FIELD SERVICE SPECIALIST (FSS) VISITED CUSTOMER SITE AND UPDATED CUSTOMER FOR CHANGING THE SUBSYSTEM CONTROLLER (SSC) PRINTED CIRCUIT BOARD (PCB). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE SPECIALIST (FSS) VISITED CUSTOMER SITE AND REPLACED THE SUBSYSTEM CONTROLLER PRINTED CIRCUIT BOARD (PCB). THE SYSTEM MEETS AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LABELING, TRENDING AND RISK DOCUMENTATION REVIEWS FOR THIS EQUIPMENT WERE PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE RECEIVED COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED OF BURNING SMELL FROM THE SOVEREIGN COMPACT CONSOLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO PATIENT TREATMENTS DELAYED OR CANCELLED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS VISIBLE SMOKE COMING FROM THE CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440586 SOVEREIGN COMPACT CONSOLE PHACOFRAGMENTATION UNIT HQC ABBOTT MEDICAL OPTICS CMP680300 05050474514706

    Patients

    Seq Age Sex Outcome Treatment
    1