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

Model Number EZ-100

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

Nephron pharmaceuticals corp received a product complaint of a loose washer malfunction on (b)(6)2014, that was reported as associated with the use of the ez breathe atomizer.The pt reported that she saw a washer fall from the unit.Multiple attempts were made to reach the pt via telephone unsuccessfully; however, a follow-up report will be submitted if additional info is received from the pt during the investigation.At the time of the report, no info was available concerning the occurrence of medical harm to the pt or the purchase date of the unit.

Manufacturer Narrative

Multiple attempts were made to reach the pt via telephone unsuccessfully to confirm the medical device malfunction.The pt reported that a washer-like component fell from the device; however, it is unk if the pt was using the device during a treatment or cleaning the device with any tools that could dislodge the component.The serial number of the suspected device falls beyond the range of the serial numbers of atomizers associated with a class 1 recall from april 2013 until june 2014.The recall was associated with a choking hazard risk to the user if a washer became dislocated from the medication cup during use and fell into the pt's mouth.After the root cause was determined to be the debonding of the washer's epoxy glue during the soldering process, the mfr modified its manufacturing process and decreased the diameter of the mouthpiece.Although the root cause of the malfunction was not confirmed, a medical device report will be submitted due to the potential risk for harm associated with the dislocation of the washer from the device.

• Brand Name: EX BREATHE ATOMIZER
• Type of Device: ATOMIZER
• Manufacturer (Section D): HEALTH & LIFE (SUZHOU) CO., LTD; no 1428 xiang jiang rd; suzhou new district; suzhou, jiang su 2151 29; CH 215129
• Manufacturer Contact: 9fm no 186 jian yi rd, zhung he dist; new taipei city 23553 ; 282271300
• MDR Report Key: 4131236
• MDR Text Key: 4941919
• Report Number: 1054871-2014-00016
• 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
• Type of Report: Initial
• Report Date: 08/26/2014

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: 130201
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2014
• Distributor Facility Aware Date: 07/29/2014
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 08/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1