BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN 6000 PAINSMART IOD IV PUMP

    MDR report key: 2822073 · Received October 9, 2012

    Report

    Report Number
    1722139-2012-00994
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    August 23, 2008
    Report Date
    September 24, 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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-1870-2011.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE PUMP HAD EXPERIENCED EC45.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1