MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ HYGROSCOPIC CONDENSER HUMIDFIER; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Model Number	HME NEONATAL 50/CS
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
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.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that 5704eu hme filters have condensation inside the bags and was used on a patient.Furthermore, the customer confirmed no harm was done to the patient.
Additional Manufacturer Narrative
Result of investigation: based on the investigation and per one picture sent by the costumer of fg 5704eu we cannot confirm the reported defect since the ifu (instruction for use) states the following: ''due to the hch's high efficiency, you may see condensate in the polybag.This is normal occurrence due to the high efficiency of the hch product.'' this means that condensation inside the bag or the presence of water droplets is expected in this product.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Result of investigation: device history record for fg 5704eu with lot number 0004229546 and was reviewed and no issues were found.Based on the investigation and per one closed physical sample sent by the costumer of fg 5704eu with lot number 0004229546 we cannot confirm the reported defect since the ifu (instruction for use) states the following: ''due to the hch's high efficiency, you may see condensate in the polybag.This is normal occurrence due to the high efficiency of the hch product.'' this means that condensation inside the bag or the presence of water droplets is expected in this product and does not compromise the functionality of the product.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE¿ HYGROSCOPIC CONDENSER HUMIDFIER
• Common Device Name: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17880036
• Report Number: 8030673-2023-00352
• Device Sequence Number: 7666934
• Product Code: BYD
• UDI-Device Identifier: 10190752147126
• UDI-Public: (01)10190752147126(10)0004229546
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2023

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: HME NEONATAL 50/CS
• Device Catalogue Number: 5704EU
• Device Lot Number: 0004229546
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 10/10/2023; 12/22/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/09/2023; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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