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

Catalog Number 003003-A

Device Problem Fracture (1260)

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

Event Date 04/07/2018

Event Type  Injury  

Manufacturer Narrative

Vyaire has reached out to customer to provide the complaint device for further investigation.At this time we are currently waiting for verification that the sample will be available.If we receive any additional information or the device for further evaluation vyaire 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.Airflow could be felt and heard.Failure occurred during patient use with no report of patient harm.

• 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 91768
• Manufacturer (Section G): AMSINO MEDICAL GROUP HONG KONG CO LTD; 708 corporate center drive; pomona CA
• Manufacturer Contact: avery foster ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7598768
• MDR Text Key: 110994186
• Report Number: 2050001-2018-00114
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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-A
• Device Lot Number: J1017015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention