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

Model Number EZ-100

Device Problems Complete Blockage (1094); Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

Patient Problem Asthma (1726)

Event Date 01/16/2015

Event Type  No Answer Provided  

Event Description

Nephron pharmaceuticals corporation received a medical device malfunction of no aerosol production on (b)(6) 2015, that was reported as associated with the use of the ez breathe atomizer.The patient reported that the atomizer failed to produce an aerosol mist during an asthma attack, and he added that he required medical treatment in an ambulance and in the emergency room.During a follow-up phone call on (b)(6) 2015, the patient reported that he received the device during the (b)(6) of 2014.The patient used the device intermittently to alleviate symptoms of asthma.He added that the device initially stopped working at the beginning of the week before the medical event occurred on (b)(6) 2015; furthermore, the patient acknowledged that he did not clean the medication cup according to the device's instructions.During the event on (b)(6), the patient called 911 and was treated in an ambulance; however, the patient refused to be transported to the emergency room.After stabilizing, the patient drove to the emergency room and received albuterol via a mask and a prednisone tablet.The patient was discharged with an inhaler and prescriptions for albuterol inhalation solution, a nebulizer, a proair (albuterol) inhaler, and prednisone.The patient is a (b)(6) male with a past medical history that is significant for asthma.He reported that his asthma exacerbations are sporadic but concentrated when they occur.

Manufacturer Narrative

The potential root cause of this complaint could be the waterproof washer is not assembled at the correct position.Cause the moisture has leaked into the electrode pins area of the piezoelectric ceramic ring from outside.User did not clean the atomizer according to the cleaning instructions.These two hazardous situations and all the related risks have been identified and reduced as far as possible with effective control measures respectively.Based on the obtained info, we believe this event is likely a single fault event.According to 21 cfr part 803 "medical device reporting (mdr)", we performed the investigation for this mdr, there's no evidence to determine that the "malfunction" is likely to cause pt death or serious injury.

• Brand Name: ES BREATHE 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: 4589419
• MDR Text Key: 15901205
• Report Number: 3005442893-2015-00001
• 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
• Type of Report: Initial
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• 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: 130301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Date Manufacturer Received: 02/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASTHMANEFRIN INHALATION SOLUTION, 2.25%,; (RACEPINEPHRINE INHALATION SOLUTION, 2.25%)
• Patient Outcome(s): Other
• Patient Age: 46 YR