MAUDE Adverse Event Report: VYAIRE MEDICAL INC. HUMIDIFIER KIT 500ML 12/CS; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number HUMIDIFIER KIT 500ML 12/CS

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).At this time, the defective device has not been returned for evaluation.Therefore, the 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.

Event Description

The customer reported multiple issues on 002620-a humidifier kit 500ml 12/cs.When the flow is set to >4lpm, the humidifier squeals due to backpressure.The front part where you twist off the adapter to connect to the patient tubing does not create an orifice for flow to pass through, or is too small, resulting in increased back pressure from tubing obstruction and creating a fountain of water, dousing contents to the staff, patients, and room.There was no clear information on patient involvement.

• Brand Name: HUMIDIFIER KIT 500ML 12/CS
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12629035
• MDR Text Key: 278614363
• Report Number: 3013421741-2021-00012
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 07/02/2021

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: Health Professional
• Device Model Number: HUMIDIFIER KIT 500ML 12/CS
• Device Catalogue Number: 002620-A
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 10/13/2021
• 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