BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH1500 CLINICAL AUTOMATION SYSTEM

    MDR report key: 1903973 · Received November 20, 2010

    Report

    Report Number
    2050012-2010-01312
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    March 8, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQP
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM VENDOR HAS SUPPLIED A NEW SOFTWARE VERSION, WHICH HAS BEEN INSTALLED AND RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THE CONNECTION UNIT ON THE LH1500 SYSTEM BEGINS TO MOVE ALTHOUGH DISABLED. THIS IS A CUSTOM INSTRUMENT SYSTEM. NO PERSONNEL INJURIES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LH1500 CLINICAL AUTOMATION SYSTEM CLINICAL AUTOMATION SYSTEM JQP BECKMAN COULTER INC. LH1500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1