BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000CMS

    MDR report key: 3182750 · Received June 11, 2013

    Report

    Report Number
    1722139-2013-01717
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    December 1, 2010
    Report Date
    July 1, 2011
    Manufacturer
    MOOG DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1867-2011
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP HAD EXPERIENCED ERROR CODE 36 IN PUMP'S HISTORY. NEW PUMP SOFTWARE WAS INSTALLED. REF RECALL NUMBER Z-1867-2011.

    Description of Event or Problem · 1

    INFO RECEIVED STATES THAT PUMP HAD EXPERIENCED ERROR CODE 36. ERROR OCCURRED TWICE ON THE SAME DAY, SUBMITTED ONLY ONE CLAIM FOR BOTH ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264734 6000CMS FRN MOOG DEVICES GROUP 6000CMS

    Patients

    Seq Age Sex Outcome Treatment
    1