BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PROCESSOR®

    MDR report key: 2160956 · Received July 13, 2011

    Report

    Report Number
    2050012-2011-03083
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE OBSERVED THE INSTRUMENT FOR SIX HOURS BUT COULD NOT REPRODUCE THE PROBLEM. INSTRUMENT WAS OPERATIONAL. NO FURTHER COMPLAINT WAS RECEIVED AS OF (B)(4) 2011.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT A BELT ON HEMATOLOGY WAS NOT TURNING AND THAT THERE WAS A RUBBER SMELL COMING FROM THE POWER PROCESSOR. NO EFFECT TO PATIENT OR USER WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PROCESSOR® CALCULATOR / DATA PROCESSING MODULE FOR CLINICAL USE JQP BECKMAN COULTER, INC. POWER PROCESSOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1