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

Model Number EZ-100

Device Problems Loss of or Failure to Bond (1068); Detachment Of Device Component (1104)

Patient Problem Choking (2464)

Event Type  No Answer Provided  

Event Description

The patient's contacted (b)(4) via telephone on (b)(6) 2014, regarding a product complaint of loose washer that was reported as associated with the malfunction of the ez breathe atomizer.The pt reported that a silver ring fell from the device into his mouth while he was inhaling mist from the solution in the device.He added that he almost choked on the loose component.During a follow-up phone call on (b)(6) 2014, the pt reported that he sucked on the mouthpiece of the device, because the device did not produce a sufficient amount of mist to provide him with relief.He also added that the washer fell through the mouthpiece into his mouth; however, he was able to remove the washer without requiring any medical interventions.The pt is a (b)(6) year old male.The indication for use of the device and the pt's past medical history are unk.

Manufacturer Narrative

Company comment: this case report is serious based on the potential choking hazard.Causality is assessed as related.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; zhung he dist; new taipei 23553 ; 282271300
• MDR Report Key: 3777589
• MDR Text Key: 4360300
• Report Number: 3005442893-2014-00006
• 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: 03/07/2014

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: 120901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 04/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THE INFO IS UNK AT THIS TIME.
• Patient Outcome(s): Other
• Patient Age: 41 YR