BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAINSMART IOD

    MDR report key: 3221338 · Received July 1, 2013

    Report

    Report Number
    1722139-2013-02282
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    January 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MOOG DEVICE 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 PUMP NOT TO INFUSED ANY FLUID WHEN TESTING AT RATE 19.9 ML/HR AND FAILED ON "DOOR OPEN" AND 40 PSI TEST. REPLACED PLATEN ASSEMBLY.

    Description of Event or Problem · 1

    INFO RECEIVED STATES THAT PUMP'S DOOR PLATEN IS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297415 PAINSMART IOD FRN MOOG DEVICE GROUP PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1