MAUDE Adverse Event Report: AMSINO MEDICAL GROUP HONG KONG CO LTD HME TYPE I ADULT; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Catalog Number 003003

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2018

Event Type  Injury  

Manufacturer Narrative

Customer advocacy has reached out to customer to provide sample for the investigation.Ups label was provided to the customer.At this time, we are currently waiting for the sample.Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.

Event Description

The customer reported that the heat and moisture exchanger (hme) filter is coming apart at the seam.The customer reported that the filter did break apart during use."the ventilator alarm alerted us to the problem".

Manufacturer Narrative

Malfunction was not checked on the initial submission that has been corrected in this supplemental.

Manufacturer Narrative

The quality supplier team received the suspect component for investigation.An investigation was performed and identified the root cause of the reported issue was due to the welding horn and the bottom die out of parallel.This issue will be internally investigated within vyaire.

• Brand Name: HME TYPE I ADULT
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): AMSINO MEDICAL GROUP HONG KONG CO LTD; 708 corporate center drive; pomona CA 91768
• MDR Report Key: 7598407
• MDR Text Key: 110995032
• Report Number: 2050001-2018-00112
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 003003
• Device Lot Number: J1017015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 05/30/2018; 07/06/2018
• Supplement Dates FDA Received: 06/13/2018; 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention