BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2242242 · Received September 9, 2011

    Report

    Report Number
    1061932-2011-01442
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED. A REPLACEMENT UPS WAS SENT TO THE CUSTOMER. THE CUSTOMER RETURNED THE UPS WHEN THEY GOT THE NEW ONE; HOWEVER, IT IS NO LONGER AVAILABLE FOR EVALUATION. ROOT CAUSE WAS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT SMOKE WAS COMING FROM THE UPS (UNINTERRUPTED POWER SUPPLY) ON THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER UNPLUGGED IT AND FOUND THAT THE UPS PLUG IN THE OUTLET WAS BLACK. THERE WAS NO ARCING OR FIRE, AND THE FIRE DEPARTMENT WAS NOT CALLED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT. NO ONE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1