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

Model Number EZ-100

Device Problems Failure to Convert to Back-Up (1048); Detachment Of Device Component (1104)

Patient Problem Choking (2464)

Event Type  malfunction  

Event Description

The pt's husband contacted nephron pharmaceuticals corporation via telephone on (b)(6) 2014, to report a product malfunction of loose a plate that was reported as associated with the ez breathe atomizer.The reporter stated that the pt used the device one month ago and possibly inhaled a loose washer; however, the event was reported to nephron one month later after the atomizer stopped functioning.At that time, the reporter added that he noticed the plate a was missing from the unit when he attempted to clean the atomizer.Multiple attempts were made to reach the pt via telephone unsuccessfully; however, a follow-up letter will be mailed to the pt with delivery confirmation.Medical review: this case report is assessed as non serious; no immediate intervention was required and no imminent jeopardy occurred.

• Brand Name: EZ BREATHE ATOMIZER
• Type of Device: ATOMIZER
• Manufacturer (Section D): HEALTH & LIFE (SUZHOU) CO., LTD.; no. 1428 xiang jiang rd; suzhou new district; suzhou 2715 129; CH 2715129
• Manufacturer (Section G): HEALTH & LIFE 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: 3770858
• MDR Text Key: 16057235
• Report Number: 1054871-2014-00004
• 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
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 121001
• 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: 03/04/2014
• Distributor Facility Aware Date: 02/05/2014
• Date Report to Manufacturer: 03/04/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THIS INFORMATION IS UNK.