BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2133238 · Received May 11, 2011

    Report

    Report Number
    3006695864-2011-00036
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ISSUES ASSOCIATED WITH THE COMBUSTION OF DEVICE COMPONENTS, RESULTING IN ANY OF THE FOLLOWING: LIGHT, FLAME, SMOKE. EVAL: AT THE TIME OF THIS REPORT UPS HAS NOT BEEN AVAILABLE FOR INVESTIGATION. INFO REGARDING THE RESULTS AND CONCLUSION OF THE PART EVAL WILL BE PROVIDED IN A SUPPLEMENTAL MDR. FEEDBACK FROM POWERVAR (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 (POWERVAR - (B)(4), UPS, MEDICAL (B)(4)). ON (B)(4)-2011, DURING SERVICE TO PERFORM A BATTERY REPLACEMENT OF THE UPS, FIELD SERVICE SPECIALIST REPORTED THAT UPS STARTED FINE BUT WHEN TESTING BATTERY TIME, SMELL OF SMOKE APPEARED. AFTER A FEW SECONDS MORE, A PUFF OF SMOKE APPEARED FROM BACK OF UPS AND LID WAS HOT.

    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 UNK Other