BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRA 21R, 120V, 60HZ

    MDR report key: 2232045 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-05104
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) NOTED THAT CONDENSATION WAS DRIPPING OFF OF THE BARRIER CHAMBER ON TO THE POWER BOARD. WATER ON THE POWER BOARD SHORTED OUT THE BOARD, CAUSING THE REPORTED EFFECT. THE POWER BOARD WAS REPLACED AND A CONDENSATION SHIELD WAS INSTALLED. THE SHIELD WAS DEVELOPED BY THE CENTRIFUGE SUPPLIER FOR USE IN SUCH SITUATIONS. THE CENTRIFUGE MODEL IS OBSOLETE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A SPARKING AND FLAMES ON THE ALLEGRA 21R CENTRIFUGATION INSTRUMENT WHEN IT WAS NOT IN USE. THE UNIT WAS UNPLUGGED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRA 21R, 120V, 60HZ GENERAL PURPOSE LAB EQUIPMENT LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE JQC BECKMAN COULTER INC. ALLEGRA 21R N/A

    Patients

    Seq Age Sex Outcome Treatment
    1