BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK ATLAS

    MDR report key: 1364025 · Received January 9, 2009

    Report

    Report Number
    1217157-2008-00018
    Event Type
    Other
    Date Received
    January 9, 2009
    Date of Event
    December 11, 2008
    Report Date
    December 15, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    KQO
    PMA / PMN Number
    K932674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED THE POWER SUPPLY AND FUSES. ELECTRICAL TESTING WAS PERFORMED ON THE INSTRUMENT TO ENSURE THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE INSTRUMENT PASSED ALL ELECTRICAL SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HEARING A LOUD NOISE AND SMELLED SMOKE FROM THE ANALYZER. LATER THAT DAY, THE OPERATOR REPORTED HAVING RECEIVED AN "ELECTRICAL JOLT" WHEN THEY TOUCHED THE INSTRUMENT. THE OPERATOR THEN UNPLUGGED THE INSTRUMENT. THERE WAS NO INJURY TO THE OPERATOR AS A RESULT OF THIS EVENT. A FIELD SERVICE ENGINEER EXAMINED THE INSTRUMENT AND CONCLUDED THAT THE POWER SUPPLY AND AMP FUSES WERE BLOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEK ATLAS CLINITEK ATLAS KQO BAYER HEALTHCARE LLC 5001C

    Patients

    Seq Age Sex Outcome Treatment
    1