BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 3832112 · Received May 6, 2014

    Report

    Report Number
    3005442893-2014-00011
    Date Received
    May 6, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 14, 2014
    Manufacturer
    HEALTH & 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 THE COMPLAINT CANNOT BE IDENTIFIED, SINCE THE DEVICE WAS CONFIRMED NOT RETURN TO MANUFACTURER FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED NEPHRON PHARMACEUTICALS CORPORATION ON (B)(6) 2014, REGARDING A REPORTABLE MALFUNCTION OF NO AEROSOL PRODUCTION THAT WAS REPORTED AS ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PATIENT REPORTED THAT HE REQUIRED MEDICAL TREATMENT AT THE HOSPITAL AFTER THE ATOMIZER FAILED TO FUNCTION. DURING A FOLLOW-UP PHONE CALL ON (B)(6) 2014, THE PATIENT REPORTED THAT THE ATOMIZER DID NOT PRODUCE A MIST TO ALLEVIATE HIS ASTHMA SYMPTOMS. HE ADDED THAT THE SOLUTION DRIPPED OUT OF THE FRONT OF THE ATOMIZER. THE PATIENT STATED THAT HE CLEANED THE ATOMIZER ACCORDING TO THE PRODUCT'S INSTRUCTION. THE PATIENT USED THE DEVICE THREE TIMES SUCCESSFULLY; HOWEVER, THE DEVICE FAILED TO FUNCTION DURING HIS FOURTH TREATMENT. THE PATIENT IS A (B)(6) MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. HE IS A FORMER SMOKER. THE PATIENT REPORTED THAT A WOOD FIRE NEAR HIS HOME EXACERBATED HIS ASTHMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270705 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 130101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other NO INFORMATION WAS AVAILABLE CONCERNING| CONCOMITANT MEDICAL PRODUCTS