BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON OPTI-NEB PRO COMPRESSOR W/DISP NEB.

    MDR report key: 3000068 · Received March 8, 2013

    Report

    Report Number
    1044475-2013-00026
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 13, 2013
    Manufacturer
    TELEFLEX
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION ON THE RETURNED SAMPLE WAS CONDUCTED. THERE WERE NO OUTWARD VISUAL SIGNS OF ABUSE/ MISUSE OTHER THAN NORMAL SIGNS OF WEAR AND TEAR OVER TIME. NO DISCOLORATION OR SIGNS OF CONTAMINATION PRESENT ON THE BODY ON THE OPTI-NEB. NO CRACKS, DENTS BUT SOME LIGHT SCRATCHES AND DINGS ASSOCIATED WITH REGULAR USAGE WERE NOTED. FUNCTIONAL INSPECTION ON THE RETURNED SAMPLE WAS CONDUCTED. THE UNIT RAN WITHOUT INCIDENT. AN OXYGEN TUBE WAS CONNECTED TO THE COMPRESSOR AIR EXIT PORT AND THE OTHER END WAS CONNECTED TO A HUDSON UP-DRAFT II, OPTI-NEB NEBULIZER THAT WAS FILLED WITH TAP WATER. THE COMPRESSOR WAS TURNED ON AND THE AIR PRESSURE COMING FROM THE OPTI-NEB WAS STRONG ENOUGH TO PRODUCE A MIST THAT WAS EASILY SEEN. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AT THIS TIME SINCE THIS IS A PURCHASED FINISH GOOD FOR WHICH THE VENDOR OWNS THE DHR. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE COMPRESSOR DISCONTINUED OUTPUT OF AIRFLOW. REPORTED BY THE END-USER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98916 HUDSON OPTI-NEB PRO COMPRESSOR W/DISP NEB. NEBULIZER COMPRESSOR CAF TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1