MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. IN-LINE VALVE (P5-TEE)

Model Number	P5-TEE
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the patient requiring medical intervention while using the in-line valve, this report is being filed.The root cause has been determined to be a design limitation of the in-line valve, where leaks can occur through the pressure relief valve even when fully closed.The extent of the leak is situation-dependent and often not clinically significant but can represent a substantive fraction of the intended ventilation for neonatal and infant patients with small tidal volumes.As a result of this design limitation and reported adverse event, percussionaire has initiated internal corrective actions to update associated instructions for use and design modifications to eliminate the source of the leak.Percussionaire will initiate a field notification to all customers to inform them of the adverse event, root cause, clinical risks, along with the updated instructions for use and requested actions.To date, this event is the only reported adverse event related to the in-line valve leak.
Event or Problem Description
On june 10, 2025, sentec was notified of an incident involving four nicu patients who exhibited signs of respiratory descrepencies while receiving ipv therapy using the in-line valve (p5-tee).It was observed that the patients were receiving only 40-50% of the exhaled volume set by the ventilator, rather than the expected full returned volume.This discrepancy led to the retention of carbon dioxide (co2) in the patients.The underlying cause of the co2 retention was not initially known.As part of typical in-line valve use, the physician confirmed the pressure relief valve was fully closed for all patient cases.In an effort to identify the source of the issue, one patient was reintubated to rule out complications related to the endotracheal tube.The co2 retention persisted until the in-line valve was removed, at which point the patient's exhaled tidal volumes immediately improved.Due to the need for medical intervention in response to this event, sentec is submitting this report.

• Brand Name: IN-LINE VALVE (P5-TEE)
• Common Device Name: IN-LINE VALVE
• Manufacturer (Section D): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID 03864
• Manufacturer (Section G): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID 03864
• Manufacturer Contact: gina cunsolo ; 130 mcghee road; suite 109; sandpoint, ID 03864
• MDR Report Key: 22456912
• Report Number: 3029845-2025-00002
• Device Sequence Number: 15492692
• Product Code: BZO
• UDI-Device Identifier: 00849436000723
• UDI-Public: 00849436000723
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K905236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: P5-TEE
• Device Lot Number: 250324
• 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: 06/09/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown