BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2232166 · Received September 2, 2011

    Report

    Report Number
    2050012-2011-05125
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER MISHIMAK.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED IMMEDIATELY TO ACCESS THE DAMAGE. THE FSE REPLACED THE DEFECTIVE PARTS. THE ANALYZER IS NOW OPERATING PROPERLY AT THE CUSTOMER SITE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THERE WAS AN ELECTRICAL BURNING SMELL FOLLOWED BY SMOKE FROM THE LOWER RIGHT-HAND SIDE OF THE (B)(4) CLINICAL CHEMISTRY ANALYZER. THE ANALYSER WAS POWERED OFF AND THE LAB HAD TO BE EVACUATED DUE TO THE SMELL. THERE WERE NO INJURIES TO USERS AND NO PATIENT SAMPLES WERE IMPACTED. THERE WAS NO INJURY CAUSED TO USERS OR PATIENTS. NO PATIENT RESULTS WERE AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMAK.K. AU643-03E NA

    Patients

    Seq Age Sex Outcome Treatment
    1