MAUDE Adverse Event Report: HEALTH & LIFE (SUZHOU) CO., LTD. EZ BREATHE ATOMIZER

Model Number EZ-100

Device Problems Complete Blockage (1094); Use of Device Problem (1670); Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

Patient Problem Asthma (1726)

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

During the follow-up phone call on (b)(6) 2015, the reporter stated that the patient cleaned the atomizer with soap and water.According to the cleaning instructions, a vinegar-water solution should be used to clean the device; therefore, it is highly likely that the device became clogged after the patient cleaned the device improperly.The reporter discarded the device in the trash; therefore, the device is not available for an inspection.Based on the patient's report, power failure is not a potential root cause of the atomizer's malfunction; moreover, the device's battery light continued to activate when the batteries were switched.The mesh component of the medication cup can become clogged if the atomizer is not cleaned according to the product's instructions.Based on the patient's event description, the most probable root cause of the clogged mesh component is the improper cleaning of the device.Nephron has also ceased the commercial distribution of the ez breathe atomizer as of july 2015; therefore, no additional actions will be taken at this time.The carton labeling information for lot 121102 was not available at the time of the submission; therefore, the most current carton labeling information is attached.

Event Description

Nephron pharmaceuticals corporation received a device-related adverse event report of lack of effect on (b)(6) 2015, that was reported as associated with the malfunction of the ez breathe atomizer.The reporter, the patient's husband, stated that the atomizer failed to produce a mist to alleviate the patient's asthma exacerbation.The reporter added that the patient used soap and water to clean the unit.During a follow-up phone call on (b)(6) 2015, the patient's husband states that the atomizer activates with a green light; however, the atomizer does not produce a mist through the medication cup.The reporter added that the patient experienced an asthma attack on (b)(6) 2015, after the device failed to function; furthermore, the patient required medical treatment at the hospital's emergency room.The patient was using the device to alleviate wheezing associated with asthma; moreover, the patient only used the device once prior to the malfunction.At the time of the report, the reporter stated that he discarded the atomizer in the trash.The patient is a (b)(6) year old female with a past medical history that is significant for intermittent asthma.She does not have any known allergies, and she is a nonsmoker.The patient does not use other medications to alleviate her asthma symptoms.

• Brand Name: EZ BREATHE ATOMIZER
• Type of Device: ATOMIZER
• Manufacturer (Section D): HEALTH & LIFE (SUZHOU) CO., LTD.; no. 1428 xiang jiang road; suzhou new district, suzhou, jian su 21512 9; CH 215129
• MDR Report Key: 5381168
• MDR Text Key: 36461036
• Report Number: 1054871-2015-00007
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EZ-100
• Device Lot Number: 121102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2016
• Distributor Facility Aware Date: 12/22/2015
• Device Age: 3 YR
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR