BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAINSMART

    MDR report key: 3192500 · Received May 28, 2013

    Report

    Report Number
    1722139-2013-01281
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    July 20, 2011
    Report Date
    October 4, 2011
    Manufacturer
    MOOG DEVICE GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1869-2011
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. REF RECALL NUMBER Z-1869-2011.

    Description of Event or Problem · 1

    INFO RECEIVED STATES THAT PUMP HAD EXPERIENCED ERROR CODE 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233520 PAINSMART FRN MOOG DEVICE GROUP PAINSMART

    Patients

    Seq Age Sex Outcome Treatment
    1