MAUDE Adverse Event Report: HEALTH AND LIFE (SUZHOU) CO., LTD. EZ 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  malfunction  

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 pt 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 pt reported that he received the device during the spring of 2014.The pt 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 pt acknowledged that he did not clean the medication cup according to the device's instructions.During the event on (b)(6), the pt called 911 and was treated in an ambulance; however, the pt refused to be transported to the emergency room.After stabilizing, the pt drove to the emergency room and received albuterol via a mask and a prednisone tablet.The pt was discharged with an inhaler and prescriptions for albuterol inhalation solution, a nebulizer, a proair (albuterol) inhaler, and prednisone.The pt is a (b)(6) year old male with a past medical history that is significant for asthma.He reported that his asthma exacerbations are sporadic but concentrated with they occur.

Manufacturer Narrative

During the initial phone call on (b)(6) 2015, the pt reported that he did not clean the atomizer according to the cleaning instructions.He added that the atomizer failed to produce an aerosol mist after multiple uses; therefore, a potential root cause of the atomizer's malfunction could be the clogging of the mesh associated with the user's failure to properly clean the medication cup.During the follow-up phone call on (b)(6) 2015, the pt reported that he received medical treatment in the ambulance and refused to be transported to the emergency room due to a lack of transportation from the hospital.After the pt was stabilized, the pt drove to the hospital and received medical treatment in the emergency room.Although the pt was not admitted to the hospital, the pt's medical event did require emergency treatment to alleviate his symptoms; therefore, a 30-day report will be submitted to fda and the mfr regarding the event.

• Brand Name: EZ BREATHE ATOMIZER
• Type of Device: ATOMIZER
• Manufacturer (Section D): HEALTH AND LIFE (SUZHOU) CO., LTD.; no. 1428 xiang jiang road; suzhou new district; suzhou, jiang su 2151 29; CH 215129
• Manufacturer Contact: 9f, no 186 jian yi road, zhung he dist.; new taipei city 23553 ; 282271300
• MDR Report Key: 4501282
• MDR Text Key: 5444006
• Report Number: 1054871-2015-00001
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/06/2015,02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2015
• Distributor Facility Aware Date: 01/20/2015
• Device Age: 23 MO
• Event Location: Home
• Date Report to Manufacturer: 02/06/2015
• 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