BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAINSMART IOD

    MDR report key: 3101453 · Received April 30, 2013

    Report

    Report Number
    1722139-2013-00549
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 18, 2009
    Report Date
    November 3, 2009
    Manufacturer
    MOOG DEVICE GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1870-2011
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 STATES THAT PUMP HAD EXPERIENCED ERROR CODE 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187547 PAINSMART IOD FRN MOOG DEVICE GROUP PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1