BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAINSMART IOD

    MDR report key: 3205635 · Received June 27, 2013

    Report

    Report Number
    1722139-2013-02189
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 1, 2010
    Report Date
    January 3, 2010
    Manufacturer
    MOOG DEVIE GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IMPACT: PLATEN BENT CAUSING OVER INFUSION. REPLACED PLATEN ASSEMBLY.

    Description of Event or Problem · 1

    "THE SET CONTINUED TO DRIP EVEN AFTER THE PUMP WAS STOPPED. HE TRIED IT WITH ANOTHER SET AND IT HAPPENED AGAIN. HE SAID PUMP WAS NOT ON A PT. HE WAS PERFORMING TESTING BEFORE THE PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291870 PAINSMART IOD FRN MOOG DEVIE GROUP PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1