BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION 6000 IV PUMP

    MDR report key: 2904311 · Received November 20, 2012

    Report

    Report Number
    1722139-2012-01181
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT AFTER THE PROGRAM WAS SET, THE SET WAS PRIMED, AND THE PROGRAM WAS REVIEWED FOUND THAT THE LOADING DOSE WAS DISAPPEARED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1