BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAINSMART

    MDR report key: 3190900 · Received June 14, 2013

    Report

    Report Number
    1722139-2013-01909
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    January 1, 2000
    Report Date
    October 25, 2011
    Manufacturer
    MOOG DEVICE GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1869-2011
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 36. ERROR OCCURED FOUR TIMES ON SAME DATE, ONLY ONE REPORT WAS GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272280 PAINSMART FRN MOOG DEVICE GROUP PAINSMART

    Patients

    Seq Age Sex Outcome Treatment
    1