MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS; VITAL SIGNS¿ PEDIATRIC ANETHESIA BREATHING CIRCUIT

Model Number	1552016
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
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 16 jan 2026 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 21 cfr 803, 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 the circuit broke while being used on a patient.Patient stable but 5 minute delay in treatment as a new circuit was obtained and reconnected.
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 16 jan 2026 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 (b)(4).This information is submitted pursuant to 21 cfr 803, 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.Affected device investigation: the defect of broken circuit was able to be confirmed based on the customer photos.The defect was observed where the 073- 007042ga (wye) and 073-007043a (connector) meet with the wye broken.The most likely root cause was identified as manufacturing related, if the connector is mated to far into the wye it may cause stress to the wye that can result in cracking or breaking of the component during use.Risk assessment: patient/caregiver: this failure has been included and assessed for risk in rma-20030d-circuit rev 2 under risk id bi-sl-sha-14 with a severity of 3/5 and an p of 1/5 which equates to a low risk.A review of the past 24 months shows sales of vital signs circuits (155201x) of (b)(4) and this is the 2nd complaint for cracked/broken wye.Using the equation (b)(4) we get a p1 of 1/5.With a p2 of 1/5 we get a p of 1/5 giving a risk level of low.Per table 1b of ref-20001-c1 rev 2 this gives an overall patient risk of low.Due to the overall risk remaining as low, the same as the risk management document.Therefore, this issue does not meet the carb escalation criteria regulatory/compliance risk: this failure does not meet the requirements for increased trend of incidents for the same failure mode which means the failure mode is considered a non-violative (low risk) regulatory/compliance risk per table 2 of ref-20001-c1.Conclusion: between the 2 risk impacts, none met the carb escalation criteria.Severity: 3/5 serious, rma-20030d-circuit rev 2, bi-sl-sha-13.Device history record (dhr) review: the device history record for the part number 1552016 with lot number 0004328944 and udi code (b)(4) was reviewed in order to detect any issue related with the reported defect, the complete lot was manufactured, inspected and released on 30jun2025 per our internal procedures and no issues were found.Complaint history review: this is the second complaint in the past 24 months for product with wye related to cracking/broken wye.
Event or Problem Description
It was reported that the circuit broke while being used on a patient.Patient stable but 5 minute delay in treatment as a new circuit was obtained and reconnected.

• Brand Name: VITAL SIGNS
• Common Device Name: VITAL SIGNS¿ PEDIATRIC ANETHESIA 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: 24104151
• Report Number: 1314417-2026-00005
• Device Sequence Number: 21414580
• Product Code: CAI
• UDI-Device Identifier: 10190752118188
• UDI-Public: (01)10190752118188(10)0004328944
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1552016
• Device Catalogue Number: 1552016
• Device Lot Number: 0004328944
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/25/2026
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown