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
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11060536
• Report Number: 8030673-2020-00137
• Device Sequence Number: 11078899
• Product Code: OFP
• UDI-Device Identifier: 10190752145153
• UDI-Public: (01)10190752145153
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE¿ ADULT HEATED WIRE CIRCUIT KIT
• Device Catalogue Number: AH202
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention