BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PROCESSOR

    MDR report key: 1913231 · Received December 2, 2010

    Report

    Report Number
    2050012-2010-01480
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQP
    PMA / PMN Number
    CL1 EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) VISITED (B)(6) 2010. THE CURRENT COMPRESSOR/RELAY WAS SHORTED. THE FSE REPLACED REFRIGERATION SLED ON (B)(6) 2010.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO SMOKE AND SMALL FLAMES OBSERVED FROM THE REFRIGERATION UNIT OF POWER PROCESSOR. NO OPERATOR WAS EXPOSED TO THE SMOKE AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PROCESSOR DATA PROCESSING SYSTEM JQP BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1