MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number	AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification:(b)(4).H3: 81 other - 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.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the airlife infant non-heated circuits (6800-503) are defective.The water trap of the said products, was harder to remove than usual.The reported incident did not happen during patient use but one of the respiratory therapist at nicu department had minor lacerations when the water trap broke while he was opening it.

• Brand Name: AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT
• Common Device Name: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• 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: 17331012
• Report Number: 8030673-2023-00336
• Device Sequence Number: 15304912
• Product Code: BZE
• UDI-Device Identifier: 10190752157408
• UDI-Public: (01)10190752157408(10)4170314
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K915226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2023

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¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT
• Device Catalogue Number: 6800-503
• Device Lot Number: 4170314
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 07/17/2023
• 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
• Patient Sex: Unknown