MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE ADULT HEATED WIRE CIRCUIT SINGLE-LIMB, SINGLE-HEATED CIRCUIT; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number	CIRCUIT, ADULT, HEATED SINGLE LIM
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that one of the ah102 - circuit, adult, heated single limb was missing the tip or the attachment.The customer confirmed that there was no patient harm/injury associated with the reported event.
Additional Manufacturer Narrative
H3: 81 other - the customer did not send physical sample, pictures, or provide a lot number since the sample was not available for evaluation.Therefore, no root cause could be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : no sample.

• Brand Name: AIRLIFE ADULT HEATED WIRE CIRCUIT SINGLE-LIMB, SINGLE-HEATED CIRCUIT
• Common Device Name: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17419972
• Report Number: 8030673-2023-00339
• Device Sequence Number: 21003816
• Product Code: BZE
• UDI-Device Identifier: 10885403416668
• UDI-Public: (01)10885403416668
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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: CIRCUIT, ADULT, HEATED SINGLE LIM
• Device Catalogue Number: AH102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/28/2023
• 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