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

Model Number	CIRCUIT,INFANT SL,HTD CONTINUOUS-FLOW,CHAMBER
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, 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 or Problem Description
It was reported to vyaire medical that the humidifier was not heating due to a bent prong on airlife¿ infant single limb heated wire circuit kit.The reported issue occurred during patient use and the circuit was changed.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: AIRLIFE¿ INFANT SINGLE LIMB 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
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 16908551
• Report Number: 8030673-2023-00317
• Device Sequence Number: 20207950
• Product Code: OFP
• UDI-Device Identifier: 10190752145122
• UDI-Public: (01)10190752145122(10)0004185830
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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: CIRCUIT,INFANT SL,HTD CONTINUOUS-FLOW,CHAMBER
• Device Catalogue Number: AH132
• Device Lot Number: 0004185830
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/10/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown