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

Model Number	A4UX2XXX
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 08 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 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 holdings complaint database and identified as (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 an airlife product is defective or caused serious injury.
Event or Problem Description
It was reported that the anesthesiologist discovered the manual ventilation bag was ruptured approximately one hour after use began.Manual ventilation was not being performed at the time of discovery.The patient's health status remained stable, with no reported issues.There was no delay in therapy, and no harm or injury resulted from this event.
Additional Manufacturer Narrative
The product associated with the complaint was not returned for evaluation, and no photographic or videographic evidence was provided.In the absence of visual documentation, the complaint could not be confirmed; furthermore, without a sample for functional testing, the root cause could not be determined.There have been no other complaints regarding this part or any similar issue in the 24 months preceding this event.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 26 mar 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 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 holdings 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 an airlife product is defective or caused serious injury.
Event or Problem Description
It was reported that the anesthesiologist discovered the manual ventilation bag was ruptured approximately one hour after use began.Manual ventilation was not being performed at the time of discovery.The patient's health status remained stable, with no reported issues.There was no delay in therapy, and no harm or injury resulted from this event.

• 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; baja california, 21397 ; MX 21397
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 24012988
• Report Number: 1314417-2026-00003
• Device Sequence Number: 9405872
• Product Code: CAI
• UDI-Device Identifier: 10889483592618
• UDI-Public: (01)10889483592618
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: A4UX2XXX
• Device Catalogue Number: A4UX2XXX
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown