BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2033106 · Received February 28, 2011

    Report

    Report Number
    3006695864-2011-00012
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    March 12, 2009
    Report Date
    February 28, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE: (ISSUES ASSOCIATED WITH THE COMBUSTION OF DEVICE COMPONENTS, RESULTING IN ANY OF THE FOLLOWING: LIGHT, FLAME, SMOKE). AT THE TIME OF THIS REPORT THE 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 POWERVAR (UPS SUPPLIER) ON THIS ISSUE: 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. LASER WAS CHECKED BY A FIELD SERVICE ENGINEER AND PREVENTATIVE MAINTENANCE WAS COMPLETED. LASER WAS OK.

    Description of Event or Problem · 1

    INTRALASE LASER FS2 IS USED WITH AN UNINTERRUPTIBLE POWER SUPPLY (B)(4). ON (B)(6) 2009, ACCOUNT REPORTED THAT THE UPS WAS DEFECTIVE DUE TO AN AC ISSUE. THE FIELD SERVICE ENGINEER REPORTED THAT THE REPLACEMENT UPS THEN "EXPLODED" WITH VISIBLE SMOKE AFTER A ROUTINE WEEKLY POWER SHUTDOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other