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

Model Number EZ-100

Device Problem Failure to Deliver (2338)

Patient Problem Asthma (1726)

Event Date 11/06/2013

Event Type  No Answer Provided  

Event Description

The pt contacted (b)(4) on (b)(6) 2013, regarding a product complaint of no aerosol production associated with the ez breathe atomizer.The patient reported that the atomizer failed to produce an aerosol mist to alleviate his symptoms of an asthma attack.During a follow-up phone call on (b)(6) 2013, the pt reported that he went to the hospital on (b)(6) 2013, after the atomizer produced a small amount of mist.The patient was released from the emergency room after receiving nebulizer treatments and a prescription for prednisone.The patient is a (b)(6) male.He reported that he did not use any other medications and added that he is a former smoker.His past medical history is significant for asthma and unk psychological disorders.He reported that he is allergic to neurontin (gabapentin) due to vomiting and convulsions.Medical review: info regarding the prescription date, prior use and expiration date of the product were not provided.Asthma triggers and prior medical history were not provided.

Manufacturer Narrative

An eval of this failure mode from the design failure modes and effects analysis of this product, that the use of the product in a manner likely to cause adverse health consequences is improbable.The root cause of this complaint cannot be identified, since the device was not returned yet.The complete investigation results will be included in the closure report, which will be submitted by january 21, 2014.

• 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 ; CH
• Manufacturer (Section G): HEALTH & LIFE (SUZHOU) CO., LTD.; no. 1428 xiang jiang road; suzhou new district; suzhou, jiang su ; CH
• Manufacturer Contact: 9f, no 186 jian yi road, zhung he; district., new taipei city ; 282271300
• MDR Report Key: 3594744
• MDR Text Key: 4092108
• Report Number: 3005442893-2013-00098
• 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: 12/05/2013

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2013
• Initial Date FDA Received: 01/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR