BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVESCAN WAVEFRONT SYSTEM WS1

    MDR report key: 3120850 · Received May 20, 2013

    Report

    Report Number
    3006695864-2013-00168
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HKO
    PMA / PMN Number
    K000327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AT THE CUSTOMER LOCATION AND FOUND THAT THE POWER SUPPLY HAD A BURNT ODOR. THE POWER SUPPLY WAS REPLACED AND THE SYSTEM WAS TESTED AND PLACED BACK INTO SERVICE. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT THE SYSTEM GAVE OFF A BURNING SMELL AND SMOKE WAS OBSERVED COMING FROM THE COMPUTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222071 WAVESCAN WAVEFRONT SYSTEM WS1 REFRACTIVE MEASUREMENT HKO ABBOTT MEDICAL OPTICS WS1

    Patients

    Seq Age Sex Outcome Treatment
    1