MAUDE Adverse Event Report: WESTMED LLC DISPOSABLE ANESTHESIA CIRCUIT; PEDIATRIC CIRCUIT, 108" EXPANDABLE CIRCUIT

Model Number	9444
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that: we have noticed an increase in fico2 not returning to baseline therefore resulting in an increase in co2 on pediatrics less than 10 kg, but especially less than 5 kg.I removed the filter and the fico2 and etco2 quickly returned to zero and within a normal range.
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 10 oct 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 (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 stated that: we have noticed an increase in fico2 not returning to baseline therefore resulting in an increase in co2 on pediatrics less than 10 kg, but especially less than 5 kg.I removed the filter and the fico2 and etco2 quickly returned to zero and within a normal range.
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 10 oct 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 "not working normally" regarding part 9444 was not confirmed.The root cause was not determined.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.This failure has not been included and assessed for risk in rma-20030a.A request to add the risk has been added under id ru219.A pra has been issued and identified that the harm is included in ref-20003-c1 under id c-h117 with a severity of 3/5.This is the first complaint for the issue of to much dead space giving us an occurrence of 1/5.Per table 1b of ref-20001-c1 rev 2 this gives an overall patient risk of low.Due to the overall patient risk of low, the issue does not meet the carb scalation criteria.

• Brand Name: DISPOSABLE ANESTHESIA CIRCUIT
• Common Device Name: PEDIATRIC CIRCUIT, 108" EXPANDABLE CIRCUIT
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED JAVID DE MEXICO, S.A. DE C.V; carretera internacional km 6.5; edif 18; parque industrial nog; nogales sonora, mexico 84094 ; MX 84094
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 23273638
• Report Number: 2028807-2025-00022
• Device Sequence Number: 8872508
• Product Code: CAH
• UDI-Device Identifier: 00709078008245
• UDI-Public: (01)00709078008245(10)0004329081
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 9444
• Device Catalogue Number: 9444
• Device Lot Number: 0004329081
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 12/10/2025
• 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