BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 4101370 · Received August 29, 2014

    Report

    Report Number
    1054871-2014-00018
    Event Type
    Malfunction
    Date Received
    August 29, 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
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THIS CASE REPORT, THE PATIENT REPORTED THAT THE ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST DESPITE CLEANING THE MEDICATION CUP ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS AND CHANGING THE BATTERIES. THE PATIENT ADDED THAT HE SPECIFICALLY CLEANED THE DEVICE WITH ALCOHOL, VINEGAR, AND DISTILLED WATER; HOWEVER, THE ATOMIZER BECAME CLOGGED AND FAILED TO PRODUCE AN AEROSOL MIST. HE ALSO ADDED THAT THE ATOMIZER FAILED TO ACTIVATE DESPITE USING NEW BATTERIES. AT THIS TIME, THE PATIENT HAS NOT RETURNED THE ATOMIZER ASSOCIATED WITH THE MALFUNCTION. THE PATIENT REPORTED THAT HE WILL NOT RETURN THE ATOMIZER BASE UNIT ASSOCIATED WITH THE MALFUNCTION DESPITE RECEIVING A REPLACEMENT ATOMIZER; HOWEVER, THE PATIENT DID REPORT THAT HE WILL SEND THE MEDICATION CUP FROM THE SUSPECTED DEVICE BACK TO THE MANUFACTURER FOR ANALYSIS. THE PATIENT DOES HAVE AN EXTENSIVE HISTORY OF COMMUNICATION WITH THE MANUFACTURER CONCERNING REPLACEMENT PRODUCT REQUESTS. ALTHOUGH PLAUSIBLE, IT IS UNLIKELY THAT THE MANUFACTURER CAN DETERMINE THE ROOT CAUSE OF THE BATTERY MALFUNCTION AND THE MESH OCCLUSION MALFUNCTION WITHOUT ALL COMPONENTS OF THE ATOMIZER. ALTHOUGH THE ROOT CAUSES OF THE MALFUNCTIONS WERE NOT DETERMINED, A MEDICAL DEVICE REPORT WILL BE SUBMITTED DUE TO THE POTENTIAL RISK FOR HARM IF THE MALFUNCTION RECURRED.

    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 BREATHE ATOMIZER. THE PATIENT 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 PATIENT REQUESTED THAT NEPHRON REFRAIN FROM CONTACTING HIM CONCERNING FOLLOW-UP QUESTIONS; THEREFORE, NO ADDITIONAL INFORMATION IS AVAILABLE CONCERNING THE NATURE OF THE MALFUNCTION, MEDICAL HARM OR THE PATIENT'S PAST MEDICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527736 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH AND LIFE (SUZHOU) CO., LTD. EZ-100 0110067562

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR