BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZE

    MDR report key: 4146806 · Received September 30, 2014

    Report

    Report Number
    3005442893-2014-00019
    Date Received
    September 30, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 29, 2014
    Manufacturer
    HEALTH AND LIFE (SUZHOU) CO. LTD
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THIS FAILURE MODE FROM THE DESIGN FAILURE MODES AND EFFECTS ANALYSIS OF THIS PRODUCT, THAT THE USE OF THE PRODUCT IN A MANNER LIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCE IS IMPROBABLE. HEREWITH THE CLOSURE REPORT AS ATTACHMENT, THE ROOT CAUSE OF THIS COMPLIANT HAS BEEN IDENTIFIED AS THE WATERPROOF WASHER IS NOT ASSEMBLED AT THE CORRECT POSITION.

    Description of Event or Problem · 1

    NEPHRON PHARMACEUTICALS CORP RECEIVED A REPORT OF A DEVICE MALFUNCTION ON (B)(6) 2014, ASSOCIATED WITH THE USE OF THE EZ BREATH ATOMIZER. THE PT REPORTED THAT THE ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST DESPITE CLEANING THE ATOMIZER ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS AND CHANGING THE BATTERIES. THE PT REQUIRED THAT NEPHRON REFRAIN FROM CONTACTING HIM CONCERNING FOLLOWUP QUESTIONS; THEREFORE, NO ADDITIONAL INFORMATION IS AVAILABLE CONCERNING THE NATURE OF THE MALFUNCTION, MEDICAL HARM, OR THE PT'S PAST MEDICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608128 EZ BREATHE ATOMIZE ATOMIZER CCQ HEALTH AND LIFE (SUZHOU) CO. LTD EZ-100 130301

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR THIS INFORMAITON IS UNK