BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER

    MDR report key: 6027108 · Received October 13, 2016

    Report

    Report Number
    3003898360-2016-00952
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 3, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND THERE WERE NO DEFECTS OBSERVED. FUNCTIONAL TESTING WAS ALSO PERFORMED AND NO LEAKS WERE DETECTED. THE REPORTED COMPLAINT OF "AIR LEAKAGE DURING USE ON PATIENT" WAS NOT CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE RETURNED BREATHING EXERCISER WAS ABLE TO PASS A FUNCTIONAL INSPECTION WHEN CONNECTED TO VACUUMED AIR. ALL THREE INNER BALLS WERE ABLE TO MOVE WITHIN THE BREATHING EXERCISER WHEN THE FLOWMETER WAS SET TO THE APPROPRIATE PRESSURE. THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED SAMPLE. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE DEVICE INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE DEVICE HAS NOT BEEN RETURNED AT THE TIME OF THIS REPORT. THIRTEEN SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION (8884717395) LOT # 73J1600663, A QUALITY INSPECTION WAS PERFORMED ON THE SAMPLES, AND ISSUE REPORTED "AIR LEAKAGE" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER FOR THE DEVICE INVOLVED WAS NOT PROVIDED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED AS IT IS NECESSARY TO RECEIVE THE DEVICE SAMPLE TO PERFORM A PROPER INVESTIGATION , AND CONFIRM THE ALLEGED DEFECT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT AIR LEAKAGE FROM THE PRODUCT WAS CONFIRMED DURING USE. NO HARM OR INJURY TO PATIENT WAS REPORTED. THE PATIENT CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT AIR LEAKAGE FROM THE PRODUCT WAS CONFIRMED DURING USE. NO HARM OR INJURY TO PATIENT WAS REPORTED. THE PATIENT CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679944 HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER INCENTIVE SPIROMETER BWF TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1