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	12/09/2020
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.
Event or Problem Description
The customer reported that the airlife¿ adult heated wire circuit kit experienced heated high flow water chamber separate from the metal plate from lot number (b)(4).The customer confirmed that the patient became hypoxic.Patient was placed on a non-rebreather mask until the heater chamber could be replaced.

• 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: 11112393
• Report Number: 8030673-2020-00140
• Device Sequence Number: 14433697
• Product Code: OFP
• UDI-Device Identifier: 10190752145153
• UDI-Public: (01)10190752145153(10)CM20K12
• 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
• Report Date (Section B): 12/09/2020

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
• Device Lot Number: CM20K12
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/04/2021
• 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