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

Model Number	A50605-D
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was originally submitted in december 2023 as a 5-day report; however, an error occurred while submitting and is being submitted in january of 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 recently submitted field safety corrective action (fsca) that may pose risk to the end user.It has been determined through investigation of similar malfunctions, that some phasitron breathing circuits may be defective due to a manufacturing issue.The recall reference is (b)(4).In relation to this adverse event, due to the patient experiencing a pneumothorax and requiring medical intervention, this event is considered reportable.The complaint was received on december 14th via email after notification of the fsca, therefore information on the event and product are still in process of being compiled at this time.The product is in process of being sent back to the manufacturer for formal investigation.Based on other customer feedbacks received of similar events, 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.Furthermore, a functional evaluation will be implemented for devices to undergo testing prior to final release.A follow up mdr will be submited if any additional information is received on this event.
Event or Problem Description
A customer complaint was received by percussionaire's distributor after the customer was notified of an urgent field safety corrective action.In response to the percussionaire field safety notification, the customer stated on (b)(6) a nicu patient experienced a pneumothorax after using the phasitron device.The customer noted that the device seemed to be making a high pitched noise and exhibiting high pressures, despite attempting to reduce the pressure output.

• 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: 18576339
• Report Number: 3029845-2024-00024
• Device Sequence Number: 7922764
• Product Code: CBK
• UDI-Device Identifier: 00849436000259
• UDI-Public: 00849436000259
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: 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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: Not provided
• 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: Other
• Patient Sex: Unknown