MAUDE Adverse Event Report: VYAIRE MEDICAL INC. HME TRACHEOSTOMY 50/CS; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Model Number HME TRACHEOSTOMY 50/CS

Device Problem Material Deformation (2976)

Patient Problem Dyspnea (1816)

Event Date 12/07/2022

Event Type  Injury  

Event Description

It was reported to vyaire medical that the sponge part of the 3014 hme tracheostomy 50/cs had hardened.Mild dyspnea was noted when attempting to change the heat moisture exchanger (hme) tracheostomy.

Manufacturer Narrative

The sample has been discarded but i requested the sales person to conduct a bit more detailed investigation through the hospital staff.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

Results of investigation: based on a series of investigation and analysis, as well as sample tests of the same model, no related problems occurred.Vyaire medical believes that this problem is unlikely due to the raw materials and process, vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: HME TRACHEOSTOMY 50/CS
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): AMSINO MEDICAL (SHANGHAI) CO. LTD; building no. 1-3, lane 355 hua; songjiang export processing zo; shanghai 20161 3; CH 201613
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16080684
• MDR Text Key: 306453183
• Report Number: 3013421741-2022-00026
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

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 Model Number: HME TRACHEOSTOMY 50/CS
• Device Catalogue Number: 3014
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 03/27/2023
• 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