MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS; VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT

Model Number	AMY520X4F
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there have been a few instances where the patient showed high peep with low tidal volume, making it difficult for practitioners to properly ventilate the patient.In some cases, they removed the circuit and used an ambu bag, successfully ventilating the patient.The hme occluded during use and did not allow any air to pass through it.The hme became a brick wall at the filter.While there was no reported injury to the patient if it were to reoccur, there is a possibility of serious harm or injury to the patient and a delay in therapy.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 29 aug 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.
Event or Problem Description
It was reported that there have been a few instances where the patient showed high peep with low tidal volume, making it difficult for practitioners to properly ventilate the patient.In some cases, they removed the circuit and used an ambu bag, successfully ventilating the patient.The hme occluded during use and did not allow any air to pass through it.The hme became a brick wall at the filter.While there was no reported injury to the patient if it were to reoccur there is a possibility of serious harm or injury to the patient and a delay in therapy.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 29 aug 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint - (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.The complaint of "occlusion" regarding part amy520x4f was confirmed.The root cause was determined as material.A risk assessment was performed, and the ultimate risk was determined to be low which does not require escalation to the capa review board.There have been 0 other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

• Brand Name: VITAL SIGNS
• Common Device Name: VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 22929347
• Report Number: 1314417-2025-00065
• Device Sequence Number: 13335734
• Product Code: BTM
• UDI-Device Identifier: 10889483596258
• UDI-Public: (01)10889483596258(10)0004329142(11)250718(17)271106
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: AMY520X4F
• Device Catalogue Number: AMY520X4F
• Device Lot Number: 0004329142
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 08/29/2025
• 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: Other
• Patient Sex: Unknown