BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD

    MDR report key: 5350183 · Received January 7, 2016

    Report

    Report Number
    5350183
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    October 28, 2014
    Report Date
    November 16, 2015
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BODY GUARD INFUSION PUMP FAILED UPON SET UP AND REQUIRED A HARD RESET-DISPLAY "ERROR". PUMP TAKEN OUT OF SERVICE AND TAKEN TO BIOMED. THIS IS ONE OF MANY FAILURES OF THESE PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10943 BODYGUARD PUMP, INFUSION FRN CME AMERICA, LLC 121

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR