BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2761137 · Received August 29, 2012

    Report

    Report Number
    2761137
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    April 16, 2012
    Report Date
    August 29, 2012
    Manufacturer
    MOOG, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT BROUGHT IN HIS MOOG PAIN PUMP STATING THAT IT WOULD NOT TURN OFF WHEN TURNED TO ZERO. RN AND M.D.A. VERIFIED THAT IT WAS INDEED STILL DRIPPING AT THE ZERO SETTING. THE SALES REP FROM MOOG ALSO OBSERVED PUMP DRIPPING AT ZERO. A MINOR INJURY TO THE PATIENT WAS REPORTED. THE DEVICE WAS RECEIVED BY CLINICAL ENGINEERING AND PERTINENT DATA WAS LOGGED. THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR AN ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PUMP, INFUSION FRN MOOG, INC. MVBXL-CPNB *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR