BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS2

    MDR report key: 3893122 · Received June 25, 2014

    Report

    Report Number
    3006695864-2014-00311
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AND FOUND CHARRED AND ARCED POWER CABLE. THE A/C (ALTERNATE CURRENT) RECEPTACLE AS WELL AS THE SWITCHING POWER SUPPLY'S FAIL TO OUTPUT +5, 12 AND 15 VOLTS. HE REPLACED THE POWER CABLE, RECEPTACLE, AND SWITCHING POWER SUPPLY. EQUIPMENT MEETS AMO SPECIFICATION ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT SYSTEM POWERS ON, THEN RIGHT BEFORE THE WARM-UP IT, SHUTS DOWN WITH NO ERROR MESSAGES. THE CUSTOMER ATTEMPTED TROUBLESHOOTING BUT NO CHANGES WERE OBSERVED. NO PATIENT WAS INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370198 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other