MAUDE Adverse Event Report: PERCUSSIONAIRE PHASITRON BREATHING CIRCUIT; PHASITRON KIT, VDR

Model Number	A50094-D
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a customer that during treatment on a patient, the internal component that aids in providing pulsation within the phasitron breathing circuit was sticking, inhibiting proper treatment.The patient experienced slight desaturation.No additional patient information provided.
Additional Manufacturer Narrative
This event is being reported due to the failure of the phasitron used with the vdr ventilator, which is a life-sustaining device, while in use on a patient.It was stated by the customer that the internal venturi component was getting stuck within the device, disrupting adequate percussive ventilation.It was communicated that the patient experienced slight desaturation, but no other adverse events were reported.The customer also stated that they had four phasitron breathing circuits experiencing this issue.This event was investigated by evaluating the a50094-d phasitrons at percussionaire, as the customers device was only received november 19th.It was determined that the venturi, a component within the phasitron device that takes part in providing percussive ventilation to the patient, is getting stuck to the internal diameter of the phasitron body.After further assessment, it was realized that the design dimension specifications of the internal venturi are not accurate.This assessment is ongoing internally and percussionaire is in process of assessing the need for a fsca.Currently, percussionaire has only received one customer complaint on this isue.Complaints will be monitored on this issue and escalated accordingly.If any additional information is received on this event, a follow up mdr will be submitted.

• Brand Name: PHASITRON BREATHING CIRCUIT
• Common Device Name: PHASITRON KIT, VDR
• Manufacturer (Section D): PERCUSSIONAIRE; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer (Section G): PERCUSSIONAIRE; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer Contact: gina cunsolo ; 130 mcghee road; suite 109; sandpoint, ID 83864
• MDR Report Key: 20758020
• Report Number: 3029845-2024-00048
• Device Sequence Number: 8393217
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: A50094-D
• Device Catalogue Number: A50094-D / A50094-D-5PK
• Device Lot Number: WO07196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown