MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ ADULT HEATED WIRE; VENTILATOR BREATHING CIRCUIT, SINGLE-USE

Model Number	AIRLIFE¿ ADULT HEATED WIRE
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the airlife¿ adult heated wire circuit dual-limb, dual-heated circuit experienced circuits became flooded with water.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.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
• Common Device Name: VENTILATOR BREATHING CIRCUIT, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12715860
• Report Number: 8030673-2021-00207
• Device Sequence Number: 20030397
• Product Code: BZE
• UDI-Device Identifier: 10190752145146
• UDI-Public: (01)10190752145146
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE¿ ADULT HEATED WIRE
• Device Catalogue Number: AH180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown