BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 3102428 · Received April 30, 2013

    Report

    Report Number
    1641965-2013-00021
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Report Date
    April 1, 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

    THE REPORTED COMPLAINT WAS NOT CONFIRMED, NOR DUPLICATED. THE PUMP OPERATION LOG GIVES NO INDICATION OF THE REPORTED PROBLEM BUT DOES INDICATE SYSTEM ERROR 75 OR SYSTEM ERROR 123 WHICH TYPICALLY ACCOMPANY A NON-RESPONSIVE KEYPAD. THEREFORE, THE PUMP WAS TESTED (RUN) FOR 24 HOURS AS PART OF THIS INVESTIGATION. THERE WERE NO FAILURES DURING THAT PERIOD. THE KEYPAD WAS RESPONSIVE DURING THE INVESTIGATION OF THIS PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, KEYPAD REPORTED TO FREEZE WHEN IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187730 OUTLOOK ES INFUSION PUMP FRN B. BRAUN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention