BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA MAX, 130K ULTRACENTRIFUGE, 120V

    MDR report key: 2232027 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-05103
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) NOTED THAT THE VACUUM PUMP OIL WAS LEAKING INTO THE DIFFERENTIAL PUMP, CAUSING THE BURNING SMELL. FSE FLUSHED THE VACUUM PUMP SEVERAL TIMES, REPLACED THE OIL, OIL FILTER, AND THE VACUUM PUMP MUFFLER ASSEMBLY. THE FSE REPAIRED THE UNIT AND TESTED IT TO CONFIRM PROPER OPERATION WITH NO FURTHER BURNING SMELL. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT A BURNING SMELL FROM THEIR OPTIMA MAX ULTRACENTRIFUGE. NO REPORT OF INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA MAX, 130K ULTRACENTRIFUGE, 120V GENERAL PURPOSE LABORATORY EQUIPMENT LABELED OR PROMOTED FOR A SPECIFIC MEDICAL JQC BECKMAN COULTER INC. OPTIMA MAX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1