MAUDE Adverse Event Report: HEALTH AND LIFE (SUZHOUR CO. LTD. EZ BREATH ATOMIZE; ATOMIZER

Model Number EZ-100

Device Problems Complete Blockage (1094); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2014

Event Type  No Answer Provided  

Event Description

Nephron pharmaceuticals corp received a report of a device malfunction from fda (b)(4) on (b)(6) 2014, that was reported as associated with the use of the ez breath atomizer.The maude report stated that the device ceases to function after multiple uses and is difficult to maintain.The maude report listed the event date as (b)(6) 2014 and the report date as (b)(6) 2014.During a follow-up phone call on (b)(6) 2014, the pt reported that the device became clogged after one week of use.He added that he used the product, because nephron's current asthmanefrin product reminded him of the asthma nefrin product sold with a glass atomizer when he was a child.The pt reported that he purchased the suspected product between the end of 2013 and the beginning of 2014.The pt did not experience any medical harm as a result of the malfunction.The pt is a (b)(6) year old male with a past medical history that is significant for asthma.He does not smoke, and he did not report any allergies to medications.

Manufacturer Narrative

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 complaint cannot be identified since the unit would not be returned for further analysis.

• Brand Name: EZ BREATH ATOMIZE
• Type of Device: ATOMIZER
• Manufacturer (Section D): HEALTH AND LIFE (SUZHOUR CO. LTD.; no. 1428 xiang jiang road; suzhou new district; suzhou, jiang su 2151 29; CH 215129
• Manufacturer (Section G): HEALTH & LIFE (SUZHOU) CO., LTD.; no. 1428 xiang jiang road; suzhou new district; suzhou, jiang su 2151 29; CH 215129
• Manufacturer Contact: 9f, no. 186 jian yi road; zhung he dist.; new taipei city 23553 ; 282271300
• MDR Report Key: 4347943
• MDR Text Key: 5216600
• Report Number: 3005442893-2014-00021
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EZ-100
• Device Lot Number: 120701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (RACEPINEPHRINE INHALATION SOLUTIONS, 2.25 PERECEN; ASTHMANEFRIN INHALATION SOLUTION, 2.25 PERCENT
• Patient Age: 70 YR