BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVESCAN FOURIER ALGORITHM

    MDR report key: 4338687 · Received December 17, 2014

    Report

    Report Number
    3006695864-2014-00550
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    November 26, 2014
    Report Date
    November 26, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HKO
    PMA / PMN Number
    K000327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AND SMELLED ODOR FROM ENCLOSED POWER SUPPLY ON COMPUTER. REPLACED POWER SUPPLY ASSEMBLY AND TESTED THE EQUIPMENT. SYSTEM MEETS AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: HEALTH PROFESSIONAL IS BEING CORRECTED TO YES FOR THE INITIAL MEDICAL DEVICE REPORT (MDR). HEALTH PROFESSIONAL WAS NOT INCLUDED IN THE INITIAL MDR. EVALUATION: OPERATION PROBLEM FOR RESULTS IS BEING CORRECTED TO POWER SUPPLY FOR THE INITIAL MDR. ALL PERTINENT INFORMATION AVAILABLE TO THE ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THE COMPUTER WAS NOT FUNCTIONING AND THE POWER SUPPLY FANS WERE NOT OPERATING. CUSTOMER SAW SMOKE COMING FROM BACK OF THE COMPUTER UPON POWERING UP THE WAVESCAN FOR USE. SYSTEM SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828229 WAVESCAN FOURIER ALGORITHM REFRACTIVE MEASUREMENT HKO ABBOTT MEDICAL OPTICS 0070-1006

    Patients

    Seq Age Sex Outcome Treatment
    1