BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PROCESSOR®

    MDR report key: 1843148 · Received September 23, 2010

    Report

    Report Number
    2050012-2010-00808
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQP
    PMA / PMN Number
    CL. I EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED AND REPLACED THE RELAY ASSEMBLY ON THE COMPRESSOR. SERVICE PERFORMED A CHECK WITH THE REFRIGERATION SPECIALIST OF THE HOSPITAL. THE COMPRESSOR WAS TURNED ON AND SHOWED NORMAL PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO FLAMES AND SMOKE OBSERVED FROM THE COMPRESSOR UNIT IN POWER PROCESSOR. THE CUSTOMER DID NOT NEED THE FIRE DEPARTMENT BECAUSE THE INTERNAL BREAKER SHUT OFF. NO FIRE, INJURY DUE TO FIRE OR SMOKE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PROCESSOR® CLINICAL AUTOMATION JQP BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1