BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 3851739 · Received June 5, 2014

    Report

    Report Number
    2020664-2014-00044
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER WAS CHECKED IN ERROR. THE CATEGORIES ARE FOR OUTCOMES ATTRIBUTED TO AN ADVERSE EVENT. THE CATEGORIES ARE NOT APPLICABLE TO THE EVENT. CORRECTED DATA: THE MANUFACTURER REPORT NUMBER SHOULD HAVE BEEN 3006695864. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA - REPORT SOURCE - HEALTH PROFESSIONAL, USER FACILITY AND COMPANY REPRESENTATIVE. WITHIN THE INITIAL REPORT, ONLY ''YES'' SHOULD HAVE BEEN SELECTED FOR DEVICE EVALUATED BY MFR. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AND THE ISSUE WAS CONFIRMED. HE REPLACED THE HARD DISC DRIVE AND CENTRAL PROCESSING UNIT BOARD TO CORRECT THE PROBLEM. SYSTEM MEETS ALL AMO SPECIFICATION AND PROBLEM IS RESOLVED. WHILE ON SITE, FOUND MAIN SWITCH WIRING BROKEN AND A CONNECTOR BROKEN ON GRAPHIC USER INTERFACE BOARD, REPLACED MAIN SWITCH AND GRAPHIC USER INTERFACE BOARD TO CORRECT THE PROBLEM, TESTED AND SYSTEM MEETS ALL AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT THE SYSTEM FROZE DURING IRRIGATION/ASPIRATION MODE. THE PHYSICIAN RELEASED THE FOOTPEDAL BUT THE VACUUM HAD STILL BEEN ACTIVE AND A SOUND WAS STILL ON. THE PHYSICIAN COULD NOT OPERATE THE DISPLAY AND THE MONITOR SCREEN TURNED BLUE. IMMEDIATELY EXCHANGED WITH AN ALTERNATIVE MACHINE. IT WAS REPORTED THAT THE EVENT OCCURRED AFTER LENS WAS IMPLANTED AND HEALON VACUUMED. NO PATIENT INJURY OR SURGICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329252 WHITESTAR SIGNATURE SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other