BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 5184508 · Received October 28, 2015

    Report

    Report Number
    3006695864-2015-00751
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    October 2, 2015
    Report Date
    December 15, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE FIELD SERVICE SPECIALIST (FSS) PERFORMED THE TWO (2) YEAR PREVENTATIVE MAINTENANCE (PM), WHICH BATTERY PACK AND SEVERAL FILTERS WERE REPLACED ON THE UNIT AS PART OF PM. FSS ALSO REPLACED THE ADVANTECH SINGLE BOARD COMPUTER (SBC) AND THE HARD DRIVE, WHICH RESOLVED THE REPORTED BLUE SCREEN ISSUE. FSS ALSO PERFORMED THE FIELD SERVICE CHECKLIST, WHICH THE SYSTEM PASSED ALL FUNCTIONAL TESTS AND IT WAS FOUND TO MEET ALL ABBOTT MEDICAL OPTICS SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    A DOCUMENT 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. THE OPERATOR MANUALS FOR THE SIGNATURE EQUIPMENT WAS REVIEWED AND DETERMINED TO INCLUDE ADEQUATE WARNINGS FOR MEDICAL COMPLICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE ABBOTT MEDICAL OPTICS FIELD SERVICE SPECIALIST REPORTED THAT BLUE SCREEN AT START UP OCCURRED WITH THE WHITESTAR SIGNATURE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO PATIENT TREATMENTS DELAYED OR CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716170 WHITESTAR SIGNATURE SYSTEM PHACOFRAGMENTATION UNIT HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1