BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN COMPACT

    MDR report key: 2082055 · Received April 26, 2011

    Report

    Report Number
    2020664-2011-00022
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS (AMO)
    Product Code
    HQC
    PMA / PMN Number
    K003638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED BY AN AMO SVC TECHNICIAN AT THE CUSTOMER'S LOCATION. THE TECHNICIAN INDICATED THE UNIT WOULD NOT START UP AND RESEATED THE SUBSYSTEM CONTROLLER BOARD RAM CHIP. THE ISSUE WAS RESOLVED. THE TECHNICIAN CALIBRATED VACUUM SETTINGS AND THE UNIT PASSED PRIME AND TUNE PROCESS. THE SYS WAS VERIFIED FOR ALL MODE OF OPERATIONS AND CALIBRATIONS. THE SYS HAS CONTINUED TO BE USED WITHOUT ANY FURTHER REPORTED INCIDENTS. THE MACHINE OPERATES TO AMO SPECIFICATIONS. NO ADD'L INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED AT THE END OF COMPLETION OF A CATARACT PROCEDURE, THE CLINIC WAS IN IRRIGATION/ASPIRATION MODE AND THE PHACOEMULSIFICATION MACHINE SHUT DOWN ON ITS OWN. IN ADDITION, THE CLINIC INDICATED THE MACHINE SHUT DOWN DURING PROCEDURE ONE WEEK PRIOR TO REPORTING. AT THE TIME, THE CLINIC WAS ABLE TO RESTART THE SAME MACHINE AND COMPLETE CASE. THE SURGEON COMPLETED THE PROCEDURES WITH A GOOD SURGICAL OUTCOME. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN COMPACT HQC ABBOTT MEDICAL OPTICS (AMO) CMP680300

    Patients

    Seq Age Sex Outcome Treatment
    1