BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 SLIDEMAKER

    MDR report key: 2091495 · Received May 17, 2011

    Report

    Report Number
    1061932-2011-00416
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) RETURNED TO THE SITE ON THE SAME DAY AND FOUND THAT COMPONENTS ON POWER SUPPLY MONITOR BOARD WERE BURNED / MELTED. ON (B)(4) 2011, FSE REPLACED BURNED POWER SUPPLY MONITOR PRINTED CIRCUIT BOARD, POWER SUPPLY, SIGNAL CABLE J5 AND VACUUM INPUT SOLENOID. A CLEAR ROOT CAUSE IS UNKNOWN. PER LABELING, BECKMAN IS COMPLIANT WITH THE FOLLOWING STANDARDS FOR THE LH 750: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT SHORTLY AFTER A BCI FIELD SERVICE ENGINEER (FSE) LEFT THE FACILITY, THE LH750 SLIDEMAKER REBOOTED ITSELF AND THE OPERATOR SMELLED AND SAW SMOKE. THE UNIT WAS POWERED OFF UNTIL THE FSE COULD RETURN. THERE WERE NO FLAMES OBSERVED. THE FIRE DEPARTMENT WAS NOT CALLED AND NO ONE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 SLIDEMAKER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1