MAUDE Adverse Event Report: AIRLIFE VITAL SIGNS; VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT

Model Number	A4YX2XX4D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the circuit was exhibiting a leak, and the blue caps were coming loose from the corrugated circuit component.A non-serious injury was noted; however, no further details were provided.
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation a review of the device history record is in-progress.All information reasonably known as of 14 jan 2026 has been included in this 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 information known 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 provided by the user facility where the incident occurred.This product incident is documented in the airlife holdings complaint database and 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 was defective or caused serious injury.
Event or Problem Description
It was reported that the circuit was exhibiting a leak, and the blue caps were coming loose from the corrugated circuit component.A non-serious injury was noted; however, no further details were provided.
Additional Manufacturer Narrative
The complaint product was returned for evaluation, and the reported event was confirmed.A disconnection defect was identified between the blue connector and the device limbs.A corrective and preventive action (capa 00557) has been opened to conduct a comprehensive investigation into the reported disconnection and to implement appropriate corrective and preventive actions.A review of complaint history over the past 24 months indicates sales of approximately 10,430,000 vital signs circuits, during which 15 complaints related to disconnection were reported.No additional trends were identified at this time.Ongoing monitoring will continue to detect any potential emerging trends.The dhr for lot 0004337495 was reviewed, and it was confirmed that the product was manufactured in accordance with applicable specifications.All information reasonably known as of 14 apr 2026 has been included in this 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 information known 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 provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and 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 was defective or caused serious injury.

• Brand Name: VITAL SIGNS
• Common Device Name: VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): AIRLIFE; 2710 northridge dr. nw, suite; grand rapids MI 49544
• Manufacturer (Section G): AIRLIFE; 2710 northridge dr. nw, suite; grand rapids MI 49544
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 24076480
• Report Number: 1314417-2026-00004
• Device Sequence Number: 10505151
• Product Code: CAI
• UDI-Device Identifier: 30889483592780
• UDI-Public: (01)30889483592780(10)0004337495(11)251015
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: A4YX2XX4D
• Device Catalogue Number: A4YX2XX4D
• Device Lot Number: 0004337495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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