BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITE STAR SIGNATURE SYSTEM

    MDR report key: 2012807 · Received March 3, 2011

    Report

    Report Number
    2020664-2011-00003
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMO FIELD SERVICE ENGINEER EXAMINED THE EQUIPMENT AT THE CUSTOMER LOCATION AND CONFIRMED THE BURNED COMPONENT AND REPLACED THE REAR PANEL CONNECTOR BOARD ASSEMBLY. THE FIELD SERVICE ENGINEER VERIFIED THE SYSTEM WAS WITHIN SPECIFICATION AFTER THE REPAIR. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE OF THE PHACOEMULSIFICATION MACHINE THEY OBSERVED SMOKE COMING FROM THE UNIT. THERE WAS NO PT INVOLVEMENT WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITE STAR SIGNATURE SYSTEM HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1