BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750

    MDR report key: 1936579 · Received December 22, 2010

    Report

    Report Number
    1061932-2010-00305
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) INDICATED THE SMELL WAS BEING GENERATED FROM THE CRT AND REPLACED IT. A CLEAR ROOT CAUSE IS UNDETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS A SMOKE SMELL GENERATED FROM THE COULTER LH 750 ANALYZER AND THE SCOPE MODULE DID NOT HAVE A DISPLAY. THE CUSTOMER UNPLUGGED THE SYSTEM FROM THE AC SUPPLY. NO FLAMES, ARCING OR SHOCK WAS REPORTED. NO DEATH, INJURY OR MEDICAL ATTENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ® LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1