BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVELERT II FLUID LEVEL SENSOR

    MDR report key: 6255700 · Received January 17, 2017

    Report

    Report Number
    1643264-2017-00038
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Date of Event
    December 7, 2016
    Report Date
    January 2, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FLN
    PMA / PMN Number
    K060123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT OF ALARM MALFUNCTION COULD NOT BE CONFIRMED. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE FUNCTIONAL TESTING PROCESS. PRODUCT PASSED FUNCTIONAL TESTING AND ALARM FUNCTION PERFORMED AS EXPECTED. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. NO PROBLEM FOUND.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEVELERT II FLUID LEVEL SENSOR DOESN'T ALARM WHEN THE FLUID BAG IS AT THE DESIRED ALARM LEVEL. NO BACKUP DEVICE AVAILABLE. PROCEDURE COMPLETED WITHOUT A FLUID MANAGEMENT DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41428 LEVELERT II FLUID LEVEL SENSOR MONITOR, ELECTRIC FOR GRAVITY FLOW INFUSION SYSTEMS FLN SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1