BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2425150 · Received January 17, 2012

    Report

    Report Number
    3006695864-2012-00005
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSIONS: AT THE TIME OF THIS REPORT, UPS HAS NOT BEEN AVAILABLE FOR INVESTIGATION. INFORMATION REGARDING THE RESULTS AND CONCLUSION OF THE PART EVALUATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR. FEEDBACK FROM (B)(4) (UPS SUPPLIER): BY ITS VERY NATURE, THE UPM WILL PROVIDE HIGH VOLTAGES AND HIGH CURRENTS NECESSARY TO PROVIDE THE UNINTERRUPTED POWER TO THE SYSTEM. IT IS LIKELY THAT, DUE TO THESE HIGH POWER LEVELS WITHIN THE UNITS, THAT ANY COMPONENT FAILURE WOULD RESULT IN THE DESTRUCTION OF THAT COMPONENT, WHICH MAY RESULT IN HEAT AND/OR SMOKE BEING MOMENTARILY GENERATED. HOWEVER, THE UNIT IS DESIGNED SO THAT THERE IS NO RISK OF FIRE, WITH THE FAULT BEING CONTAINED WITHIN THE ENCLOSURE, SAFETY MECHANISMS TO DISCONNECT THE BATTERY POWER, AND MATERIALS THAT ARE SELF EXTINGUISHING. FIELD SERVICE SPECIALIST CARRIED OUT INSPECTION AND LASER IS RUNNING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    INTRALASE LASER FS2 IS USED WITH AN UNINTERRUPTIBLE POWER SUPPLY (UPS) MFG BY (B)(4) (MODEL/MFG PART NUMBER ABCE1440-22IEC 55144-55R). DURING A PREVENTIVE MAINTENANCE OF THE FEMTOSECOND LASER EQUIPMENT, THE CUSTOMER CARE SERVICE SPECIALIST REPORTED THAT HE SAW THE UPS FIRST SMOKING AND THEN BURNING. THERE WAS NO PATIENT INVOLVEMENT DURING THE EVENT AS THE EQUIPMENT WAS BEING SERVICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS2 LASER HNO AMO MANUFACTURING USA, LLC. 20003K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other