BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2070554 · Received March 31, 2011

    Report

    Report Number
    8020030-2011-00021
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS COMPLAINT BY LEICA MICROSYSTEMS IS CONTINUING.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM (B)(6) HOSPITAL REGARDING SUB-OPTIMAL TISSUE PROCESSING FROM AN OVERNIGHT PROTOCOL COMMENCED ON (B)(6) 2011 AND COMPLETED ON (B)(6) 2011, WHICH WAS RUN USING PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1