BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRA X-22

    MDR report key: 2110397 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-02056
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED AND THE GAS DAMPER OF THE INSTRUMENT WAS REPLACED BY A FIELD SERVICE ENGINEER. AFTER REPAIR THE INSTRUMENT WAS CONFIRMED TO BE OPERATIONAL AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GAS DAMPER ON AN ALLEGRA X-22 FAILED WELL OUTSIDE OF THE DOCUMENTED WARRANTY PERIOD. AS A RESULT OF THE FAILURE, THE DOOR OF THE CENTRIFUGE FELL ON THE HAND OF A USER. THE DOOR WEIGHS APPROXIMATELY TEN POUNDS. THE USER DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED OR ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRA X-22 CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE JQC BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1