BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TJ25 CENTRIFUGE

    MDR report key: 2286668 · Received October 11, 2011

    Report

    Report Number
    2050012-2011-06159
    Event Type
    Malfunction
    Date Received
    October 11, 2011
    Date of Event
    September 14, 2011
    Report Date
    September 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER DECLINED SERVICE. THE INSTRUMENT INVOLVED IN THIS EVENT IS NOT CLASSIFIED AS A MEDICAL DEVICE BY THE FOOD & DRUG ADMINISTRATION. HOWEVER, THE ALLEGRA 25R INSTRUMENTS COMMERCIALIZED BY BECKMAN COULTER INC. ARE PHYSICALLY IDENTICAL TO THE TJ-25 INSTRUMENT IDENTIFIED IN THIS EVENT. THE TJ-25/ALLEGRA 25R EQUIVALENT IS: ALLEGRA 25R CENTRIFUGE, 208V, 60HZ PRODUCT CODE 369434. THIS DEVICE POSSESSES A PRODUCT CLASSIFICATIONS OF JQC, CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE AND IS A 510K CLASS I EXEMPT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 THE DOOR OF A TJ25 CENTRIFUGE OPENED WHILE THE ROTOR WAS STILL SPINNING. THERE WAS NO PERSONNEL CONTACT WITH THE ROTOR. INSTRUMENT "BOARD FOR LID CONTROL DEFECTIVE" AND "ROTOR IDENTIFICATION NOT POSSIBLE" ERROR MESSAGES WERE DISPLAYED DURING THE EVENT. THE OPERATOR ATTEMPTED TO CLEAR THE ERROR MESSAGES BY MODIFYING THE RUN PARAMETERS AND POWERING OFF THE INSTRUMENT. DURING INSTRUMENT TROUBLESHOOTING THE OPERATOR OBSERVED A BRIGHT BLUE SPARK, AND A SMALL AMOUNT OF SMOKE COMING FROM THE DOOR LATCH AREA. A FIRE EXTINGUISHER WAS NOT REQUIRED AND THE FIRE DEPARTMENT WAS NOT CALLED. NO ONE REQUIRED MEDICAL TREATMENT IN ASSOCIATION WITH THIS EVENT. THERE WERE NO DEATHS OR SERIOUS INJURIES ASSOCIATED WITH THIS EVENT. NO PATIENT RESULTS WERE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TJ25 CENTRIFUGE NOT A MEDICAL DEVICE JQC BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1