MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE ADULT HEATED WIRE CIRCUIT KIT; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Model Number AIRLIFE¿ ADULT HEATED WIRE CIRCUIT KIT

Device Problem Connection Problem (2900)

Patient Problem Hypoxia (1918)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported that the device is discarded since it was used on a covid patient.However, the customer sent a photo of the device for evaluation.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 that the airlife¿ adult heated wire circuit kit experienced 2 chambers come apart on patients while delivering high flow oxygen.The reported issue occurred in 2 incidents.The customer confirmed that the patients became hypoxic.Patient was placed on a non-rebreather mask until the heater chamber could be replaced.

Manufacturer Narrative

Result of investigation: picture received for investigation.Can see a chamber where the metallic plate was came off from the plastic housing.Therefore the defect reported by the customer was confirmed.Root cause traced to material used in chamber does not meet manufacturers specifications.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE ADULT HEATED WIRE CIRCUIT KIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11060536
• MDR Text Key: 223610733
• Report Number: 8030673-2020-00137
• Device Sequence Number: 1
• Product Code: OFP
• UDI-Device Identifier: 10190752145153
• UDI-Public: (01)10190752145153
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE¿ ADULT HEATED WIRE CIRCUIT KIT
• Device Catalogue Number: AH202
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention