BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOOG 6000 CMS

    MDR report key: 6676579 · Received June 26, 2017

    Report

    Report Number
    MW5070698
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    June 26, 2017
    Report Date
    June 26, 2017
    Manufacturer
    ZEVEX INC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN REPORTS BOTH MOOG 6000 CMS PUMPS ARE SHOWING DOWN AIR OCCLUSION AND REPLACE SET 4. RN CHANGED AIR SENSITIVITY TO HIGH REPLACED TUBING X3 REPLACED BATTERIES PUMP SERIAL # (B)(4), EXP 01/23/2018, (B)(4), EXP 01/23/2018 NO SIDE EFFECTS NOTED DUE TO PUMP MALFUNCTION. RN AWARE NOT TO THROW PUMPS AWAY. RN DID NOT SAY IF THE MFR CAN CONTACT THE PT REGARDING THE PUMP MALFUNCTION. DATES OF USE: (B)(6) 2013 TO ONGOING. REASON FOR USE: (B)(4) HURLER'S SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448695 MOOG 6000 CMS MOOG 6000 CMS FRN ZEVEX INC
    448696 MOOG 6000 CMS MOOG 6000 CMS FRN ZEVEX INC

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR