MAUDE Adverse Event Report: KING SYSTEMS CORPORATION JACKSON-REES BREATHING CIRCUIT; ANESTHESIA BREATHING CIRCUIT

Model Number	3771Y-WSN
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation confirmed a molding defect in the apl valve affecting specific lots.Bench testing demonstrated that the resulting pressure remained below clinically concerning levels.While elevated pressure may contribute to transient effects such as gastric insufflation or emesis, these are uncommon and typically recognized and addressed promptly by clinicians through visual or tactile feedback during use.
Event or Problem Description
A breathing circuit (jackson-rees) was reported to exhibit increased resistance during clinical use.The healthcare professional noted the bag was not deflating properly and upon inspection, observed that the triangular openings on the apl (adjustable pressure-limiting) valve seemed to be partially occluded, limiting airflow and causing increased resistance.No patient injury occurred.The report indicated that this condition could lead to elevated pressures that could potentially result in lung damage if not detected timely.

• Brand Name: JACKSON-REES BREATHING CIRCUIT
• Common Device Name: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): KING SYSTEMS CORPORATION; 15011 herriman blvd; noblesville IN 46060
• Manufacturer (Section G): KING SYSTEMS CORPORATION; 15011 herriman blvd; noblesville IN 46060
• Manufacturer Contact: trymore magomana ; 15011 herriman boulevard; noblesville, IN 46060 ; 3177766923
• MDR Report Key: 22985603
• Report Number: 1824226-2025-00001
• Device Sequence Number: 18521402
• Product Code: CAI
• UDI-Device Identifier: 00612649188683
• UDI-Public: 00612649188683
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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: 3771Y-WSN
• Device Catalogue Number: 3771Y-WSN
• Device Lot Number: 1001199506, 1001202424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown