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

Model Number EZ-100

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

Patient Problem Asthma (1726)

Event Date 08/08/2014

Event Type  No Answer Provided  

Event Description

Nephron pharmaceuticals corporation received a report of a malfunction on 08/11/2014, that was reported as associated with the use of the ez breathe atomizer.The pt reported that his atomizer became clogged after using the device despite cleaning the atomizer according to the mfr's instruction with distilled vinegar and water.The pt 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 pt 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 mfr's instructions.During the most recent event, the pt reported that the device became clogged after one treatment.The unit was purchased in 2014 (specific date unk).The pt added that he did not require any medical interventions for the event.The pt 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 root cause of this complaint cannot be identified, since the device will not be returned to mfr.Have communicated with distributor closely and try to retrieve the defective device for further investigation.But it was confirmed that device unit will not be returned.Based on the obtained info, according to 21 cfr part 803 "medical device reporting (mdr)", we performed the investigation for this mdr, there's no evidence that this "malfunction" is likely to cause pt death or serious injury.

• Brand Name: EZ BREATHE ATOMIZE
• Type of Device: ATOMIZER
• Manufacturer (Section D): 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: 4146805
• MDR Text Key: 4772128
• Report Number: 3005442893-2014-00018
• 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
• 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: 09/30/2014
• 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
• Date Manufacturer Received: 09/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR