MAUDE Adverse Event Report: HEALTH & LIFE (SUZHOU) CO., LTD. EZ BREATH 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  No Answer Provided  

Event Description

The patient's husband contacted (b)(4) 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 (b)(4) 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; 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.

Manufacturer Narrative

The root cause of this event cannot be identified, since the unit was never returned to mfr for further analysis.However, the preliminary evaluated result is determined to be similar to the event of the mdr 3005442893-2013-00003, based on the limited info.With regard to the known possible cause, health and life company have been taking preventative action and corrective action to eliminate the root cause and recurrence.Furthermore, for the complained devices, health and life has initiated voluntary recall, and the recall notification letter and required recall materials were issued and submitted on april 24 and april 30, 2013, respectively.The recall action is still on the process.

• Brand Name: EZ BREATH ATOMIZER
• 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 (Section G): HEALTH & LIFE (SUZHOU) CO., LTD.; no. 1428 xiang jiang road; suzhou new district; suzhou, jiang su 2151 29; CH 215129
• Manufacturer Contact: no. 186 jian yi rd, 9f; zhung he dist; new taipei city 23553 ; 282271300
• MDR Report Key: 3777509
• MDR Text Key: 4435710
• Report Number: 3005442893-2014-00005
• 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: Manufacturer
• 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
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 04/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THIS INFO IS UNK.
• Patient Outcome(s): Other