BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 4101372 · Received August 29, 2014

    Report

    Report Number
    1054871-2014-00017
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 8, 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

    THE PATIENT REPORTED THAT HE USED FOUR ATOMIZERS THAT BECAME CLOGGED AFTER MULTIPLE USES DESPITE CLEANING THE DEVICES ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS; HOWEVER, THE PATIENT DID NOT PROVIDE THE SERIAL NUMBERS OF THE SUSPECTED DEVICES AT THE TIME OF THE MANUFACTURER'S FOLLOW-UP PHONE CALL. THE PATIENT ALSO ADDED THAT HE DID NOT REQUIRE ANY MEDICAL TREATMENT CONCERNING HIS ASTHMA ATTACK ON (B)(6) 2014, AFTER THE ATOMIZER DID NOT PRODUCE AN AEROSOL MIST. WITHOUT THE SUSPECTED DEVICES, THE MANUFACTURER CAN NOT CONFIRM THE ROOT CAUSE OF THE MALFUNCTION AT THIS TIME; THEREFORE, ONE MEDICAL DEVICE REPORT WILL BE SUBMITTED FOR THIS PATIENT CASE ASSOCIATED WITH THE MOST RECENT EVENT ON (B)(6) 2014.

    Description of Event or Problem · 1

    NEPHRON PHARMACEUTICALS CORP. RECEIVED A REPORT OF A MALFUNCTION ON (B)(6) 2014, THAT WAS REPORTED AS ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PATIENT REPORTED THAT HIS ATOMIZER BECAME CLOGGED AFTER USING THE DEVICE DESPITE CLEANING THE ATOMIZER ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS WITH DISTILLED VINEGAR AND WATER. THE PATIENT EXPERIENCED AN ASTHMA ATTACK ON (B)(6) 2014, AND ATTEMPTED TO USE THE DEVICE TO ALLEVIATE HIS ASTHMA EXACERBATION WITHOUT SUCCESS. DURING A FOLLOW-UP PHONE CALL ON (B)(6) 2014, THE PATIENT REPORTED THAT HE HAS PURCHASED FOUR ATOMIZERS TO ALLEVIATE HIS ASTHMA SYMPTOMS; HOWEVER, ALL FOUR DEVICES HAVE BECOME CLOGGED AFTER USE DESPITE CLEANING THE ATOMIZERS ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. DURING THE MOST RECENT EVENT, THE PATIENT REPORTED THAT THE DEVICE BECAME CLOGGED AFTER ONE TREATMENT. THE UNIT WAS PURCHASED IN 2014 (SPECIFIC DATE UNKNOWN). THE PATIENT ADDED THAT HE DID NOT REQUIRE ANY MEDICAL INTERVENTIONS FOR THE EVENT. THE PATIENT IS A (B)(6) MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA AND HAY FEVER. HE HAS NEVER SMOKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527846 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH AND LIFE (SUZHOU) CO., LTD. EZ-100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other (RACEPINEPHRINE INHALATION SOLUTION, 2.25%)| ASTHMANEFRIN