BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION PAINSMART IOD IV PUMP

    MDR report key: 2243253 · Received September 1, 2011

    Report

    Report Number
    1722139-2011-00305
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    June 21, 2011
    Report Date
    August 4, 2011
    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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAINSMART IOD IV PUMP S/N (B)(4) IS UNDER RECALL Z-1870-2011.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES PUMP EXPERIENCED ERROR CODE 45.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1