BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU400 CHEMISTRY SYSTEM

    MDR report key: 1696504 · Received May 24, 2010

    Report

    Report Number
    2050012-2010-00293
    Event Type
    Malfunction
    Date Received
    May 24, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 24, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981473
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GAS SPRINGS FOR THE TOP LID WERE CHECKED ON SEMI-ANNUAL PREVENTIVE MAINTENANCE (PM) IN (B)(4) 2009. AT THE TIME, THE GAS SPRING DID NOT FAIL AS PER THE PM PROCEDURE. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE FOR THIS EVENT AND REPLACED THE GAS SPRING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN INCIDENT WITH THE USE OF THE AU400 CHEMISTRY SYSTEM. THE CUSTOMER STATED THAT THE LID FELL ON HER HEAD DURING A STARTUP. THERE WAS NO INJURY AND NO MEDICAL ATTENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU400 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1