BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL FLOWSENSOR

    MDR report key: 3082146 · Received April 12, 2013

    Report

    Report Number
    3082146
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 12, 2013
    Manufacturer
    DRAEGER MEDICAL INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    AFTER TRACH CARE ON THIS PATIENT, THE RESPIRATORY THERAPIST WENT TO CALIBRATE THE FLOW SENSOR ON THE VENTILATOR AND NOTICED THAT THE HOUSING THAT HOLDS THE FLOW SENSOR HAD A COUPLE PIECES OFF THAT ARE NORMALLY PART OF THE HOUSING. THE PIECES WERE A METAL PROTECTION GRID AND A GASKET RING. THE RESPIRATORY THERAPIST REPLACED IT WITH A NEW HOUSING AND FLOW SENSOR AND PROCEEDED TO CALIBRATE THE FLOW SENSOR. THE PATIENT TOLERATED THIS WELL AND HAD NO ADVERSE ISSUES. THE PIECES ARE TOO LARGE TO GO THROUGH THE TRACHEOSTOMY TUBE. ======================MANUFACTURER RESPONSE FOR NEONATALER FLOWSENSOR, DRAGER (PER SITE REPORTER).======================THEY ARE GOING TO HAVE THE REGULATORY DEPT EMAIL ME WITH INSTRUCTIONS ON WHAT THEY NEED AND I WILL SEND THEM BACK TO THEM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NO INTENDED PROCEDURE. NORMAL VENT CHECK AND CALIBRATION OF FLOW SENSOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158323 NEONATAL FLOWSENSOR VENTILATOR CBK DRAEGER MEDICAL INC. ISO15, PSU UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO NO OTHER THERAPIES