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

Model Number EZ-100

Device Problems Complete Blockage (1094); Device Operates Differently Than Expected (2913)

Patient Problem Arthritis (1723)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: EZ BREATHE ATOMIZER
• Type of Device: ATOMIZER
• Manufacturer (Section D): HEALTH AND LIFE (SUZHOU) CO., LTD.; no. 1428 xiang jiang rd.; suzhou new district, suzhou, jiang su 2151 29; CH 215129
• Manufacturer Contact: 9f, no. 186 jian yi rd.; zhung he dist., new taipei city 23553 ; 282271300
• MDR Report Key: 4101372
• MDR Text Key: 15322314
• Report Number: 1054871-2014-00017
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EZ-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2014
• Distributor Facility Aware Date: 08/11/2014
• Event Location: Home
• Date Report to Manufacturer: 08/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (RACEPINEPHRINE INHALATION SOLUTION, 2.25%); ASTHMANEFRIN
• Patient Outcome(s): Other
• Patient Age: 64 YR