BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION 6000 PAINSMART IOD IV PUMP

    MDR report key: 2845026 · Received October 24, 2012

    Report

    Report Number
    1722139-2012-01056
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    July 26, 2011
    Report Date
    October 15, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1870-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THAT PUMP HAD EXPERIENCED ERROR CODE 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN INFUSION 6000 PAINSMART IOD IV PUMP FRN MOOG MEDICAL DEVICES GROUP PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1