MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. PHASITRON TRANSPORT BREATHING CIRCUIT

Model Number	A50605-D
Medical Device Problem Codes	Inaccurate Delivery (2339); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per customer complaint, while the phasitron breathing circuit was used in conjunction with the bronchontron transport ventilator, a malfunction occurred in which the device delivered a higher than intended amount of pressure to the patient.This resulted in the patient experiencing pneumomediastinum, contributing to patient requiring additional intervention.
Additional Manufacturer Narrative
This mdr was originally submitted on (b)(6) 2023 as a 5-day report; however, there was an error during submission and is now being filed in jan 2024.It has been decided by the manufacturer to report this incident as a 5 day report to fda as it has been determined this event is in relation to a newly discovered field safety corrective action (fsca) that may pose risk to the end user.It has been determined through investigation of similar malfunctions, found prior to use on patients, that some phasitron breathing circuits may be defective due to a manufacturing issue.Therefore, percussionaire is in process of compiling all information related to the fsca to notify customers, as well as submit related information to fda.In relation to this adverse event, due to the patient experiencing a pneumomediastinum and requiring medical intervention, the event is considered reportable.The phasitron breathing circuit was in use with a transport branchotron ventilator; however, it was determined that the ventilator was working appropriatley and the breathing circuit was the device to malfunction.It was stated by the end user that the device delivered a higher than intended amount of pressure to the patient, resulting in the injury.The patient required medical intervention after this occurred.The product is in process of being sent back to the manufacturer for formal investigation.Based on other customer feedbacks received of similar events, again occuring prior to patient use, root cause is suspected to be a manufacturing issue with an internal valve, until confirmed otherwise.Current corrective actions include updating the manufacturing fixture for this component, as well as completing 100% internal inspection of this device to ensure all potential defective product is caught prior to completion of manufacturing.A follow up mdr will be submited if any additional information is received on this event.

• Brand Name: PHASITRON TRANSPORT BREATHING CIRCUIT
• Common Device Name: BREATHING CIRCUIT
• Manufacturer (Section D): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer (Section G): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer Contact: gina cunsolo ; 130 mcghee road; suite 109; sandpoint, ID 83864
• MDR Report Key: 18573574
• Report Number: 3029845-2024-00019
• Device Sequence Number: 7923159
• Product Code: CBK
• UDI-Device Identifier: 00849436000334
• UDI-Public: 00849436000334
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K905235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace,Notification,Inspection
• Type of Report: Initial
• Report Date (Section B): 01/24/2024

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: A50605-D
• Device Catalogue Number: A50605-D-5PK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male