BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA¿ MAX-XP TABLETOP ULTRACENTRIFUGE

    MDR report key: 2495367 · Received March 19, 2012

    Report

    Report Number
    2050012-2012-00785
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION SERVICE WAS DISPATCHED FOR THIS EVENT. THE CAUSE OF THE EVENT IS UNKNOWN AT THIS TIME. BECKMAN COULTER, INC. (BEC) INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER, INC. ASSOCIATE REPORTED DURING INITIAL START-UP, WHEN THERE IS NO TACHOMETER SIGNAL, THE DOOR WAS ABLE TO BE OPENED AND THE ROTOR WAS SPINNING ABOVE 2 METERS PER SECOND INVOLVING OPTIMA MAX-XP TABLETOP ULTRACENTRIFUGE. IN ONE SITUATION, THERE WAS NO TACHOMETER SIGNAL AND THE USER PRESSED START. SHORTLY AFTER START DISPLAYED, THE USER PRESSED START AGAIN FOLLOWED BY STOP. THE USER THEN WAS ABLE TO OPEN THE DOOR WHILE THE ROTOR WAS STILL SPINNING. IN A SECOND SITUATION, THERE WAS NO SIGNAL AND THE USER PRESSED START AND WAITED FOR AN (B)(4) DIAGNOSTIC MESSAGE. THE USER WAS ABLE TO OPEN THE DOOR WHILE THE ROTOR WAS STILL SPINNING. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA¿ MAX-XP TABLETOP ULTRACENTRIFUGE CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE JQC BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1