BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPSENSE

    MDR report key: 2295930 · Received October 2, 2011

    Report

    Report Number
    2295930
    Event Type
    Malfunction
    Date Received
    October 2, 2011
    Date of Event
    August 10, 2011
    Report Date
    October 1, 2011
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    NONIN RESPSENSE MONITORS LOST CALIBRATION SOMETIME IN JULY. ONE OR TWO OF THE 5 MACHINES LOCATED ON THE UNIT ARE KNOWN TO BE INVOLVED. NOT SURE IF THIS IS A USE ISSUE VERSUS DEVICE FAILURE. BIOMEDICAL ENGINEERING IS INVESTIGATING. DEPARTMENT IS REVIEWING POSSIBLE INVOLVED PATIENTS AND THE POSSIBILITY OF THE NEED TO RETEST IF RESULTS IMPACTED TREATMENT OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPSENSE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK NONIN MEDICAL, INC. RESPSENSE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *