BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000CMS

    MDR report key: 3190221 · Received June 10, 2013

    Report

    Report Number
    1722139-2013-01653
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    December 7, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MOOG DEVICE 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 45 IN PUMP'S HISTORY. NEW PUMP SOFTWARE WAS INSTALLED. REFERENCE RECALL NUMBER Z-1867-2011.

    Description of Event or Problem · 1

    INFORMATION RECEIVED STATED THAT PUMP HAD EXPERIENCED ERROR CODE 36.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261780 6000CMS FRN MOOG DEVICE GROUP 6000CMS

    Patients

    Seq Age Sex Outcome Treatment
    1