BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 3063443 · Received April 12, 2013

    Report

    Report Number
    1641965-2013-00006
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Report Date
    March 15, 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: WE PERFORMED A COMPREHENSIVE REPAIR ANALYSIS OF THIS PRODUCT WHICH INCLUDED AN ATTEMPT TO REPRODUCE THE REPORTED DISCREPANCY. THE LOG SHOWS A LOW BATTERY WARNING WHICH EVENTUALLY TURNS INTO A VERY LOW BATTERY WARNING WHILE SHOWING A SYSTEM ERROR 75 AND A SYSTEM ERROR 123. THERE ALARMS ARE CONSISTENT WITH A DEVICE NOT HAVING BEEN PLUGGED INTO AN APPROPRIATE POWER SOURCE, PRODUCING AN UNEXPECTED SHUT DOWN. THE REPORTED COMPLAINT WAS NOT DUPLICATED. ACTION TAKEN: THE PUMP WAS TESTED FOR A MINIMUM OF 96 HOURS WITH THE WIRELESS ACTIVE WHICH RESULTED IN NO SYSTEM ERROR 75 OR SYSTEM ERROR 123. THE KEY PANEL FUNCTIONED PROPERLY THROUGHOUT THE TESTING AS WELL AS THE BACKUP ALARM.

    Description of Event or Problem · 1

    PUMPS THAT WERE RUNNING ON PATIENTS WERE FOUND BY NURSES TO BE OFF, NO ALARMS TRIGGERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158128 OUTLOOK ES INFUSION PUMP FRN B. BRAUN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention