BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 3180109 · Received June 13, 2013

    Report

    Report Number
    1641965-2013-00039
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE REPORTED COMPLAINT WAS CONFIRMED PER THE LOG REPORT BUT THE EVENT COULD NOT BE DUPLICATED. NOTE: LOG SHOWS SE 75, 123. TESTED PUMP WITH ACTIVE WIRELESS FOR (B)(4) HOURS RESULTING IN NO SE 75, 123. PERFORMED PREVENTATIVE MAINTENANCE SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PUMP FROZE AND LOCKED UP. IT REMAINED THAT WAY UNTIL THE BATTERY WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269775 OUTLOOK ES INFUSION PUMP FRN B. BRAUN MEDICAL, INC. 621-400ES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other