MAUDE Adverse Event Report: Percussionaire Corp. A50094-D Phasitron Breathing Circuit

Catalog Number	A50094-D
Medical Device Problem Codes	Mechanical Problem (1384); Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the user reporting an observed piece of particulate in the suction port of the circuitry while using the a50094-d breathing circuit in conjunction with a vdr ventilator on a nicu patient, this event is being reported.No patient harm or injury was reported by the customer.The customer reported to remove the impacted a50094-d breathing circuit, and replaced it with a different breathing circuit device after the particulate was observed.The customer completed an initial assessment of the device before sending the affected device back to percussionaire.The customer had noted in their assessment some additional particulate within the body of the a50094-d phasitron.Images of the additional discovered particulate were sent via email to the percussionaire team.The customer then sent back the affected device to percussionaire.It was stated that the lot number of this particular device was not known, as the packaging was discarded.Additionally, percussionaire determined that the same customer, (b)(6) medical center, for this incident also reported an issue with a50094-d breathing circuits in early august of 2026.In this report, it was communicated that the internal venturi component within the body of the a50094-d phasitron breathing circuit was observed rubbing against the internal surface of the phasitron.Percussionaire requested that these lots be returned for internal investigation as well.Percussionaire began internal evaluation of the returned devices on september 11, 2026.Replication testing for this blue particulate event is still ongoing to determine exact root cause.A follow up mdr will be reported when more information becomes available.
Event or Problem Description
On (b)(6) 2026, percussionaire was notified that while a ventilated nicu patient was receiving therapy, a piece of blue particulate was identified in the suction port of the patient circuitry.The user ceased use of the breathing circuit on the patient, and replaced it with a different breathing circuit.No patient harm or injury was reported by the customer.As this device malfunction occurred while in use on a ventilated patient, this event is being reported.

• Brand Name: A50094-D Phasitron Breathing Circuit
• Common Device Name: A50094-D Phasitron Breathing Circuit
• 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 83864
• MDR Report Key: 50946051
• Report Number: 3029845-2026-00006
• Device Sequence Number: 16059621
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Catalogue Number: A50094-D
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• 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 Age: 6 MO
• Patient Sex: Male