MAUDE Adverse Event Report: PERCUSSIONAIRE TRANSPORT PHASITRON KIT, SINGLE PATIENT; PHASITRON BREATHING CIRCUIT

Model Number	A50605-D
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is being reported retrospectively, as the complaint was initially assessed incorrectly.Due to the failure of a lifesustaining device, as well as the potential delay in treatment to a patient, this event is deemed reportable.No patient adverse event or injury due to the failure of the device was communicated; the failure of the circuit was found prior to patient use.The device was requested to be returned for evaluation, however, it was not received, and therefore a difinitive root cause of the device failure could not be determined.From the reported description, the failure is similar the open transport phasitron recall (1000524541-12/15/2023-001-r) initiated in december of 2023 in relation to inaccurate pressure produced by the device due to a manufacturing assembly error.At this time, no additional information has been provided on the event.If additional information is received, a follow-up mdr will be submitted.
Event or Problem Description
This event is being submitted retrospectively due to recent reassessment of the complaint.A complaint was received by the customer stating when setting up the phasitron circuit, the circuit would automatically go to certain pressure and nothing could be done to correct the issue.The customer replaced the circuit and discovered the second experienced the same issue.No patient harm or injury was reported.This was found prior to patient use.However, as there was a malfunction to a life-sustaining product with the possibility of harm is defective product is used, this event is being reported.

• Brand Name: TRANSPORT PHASITRON KIT, SINGLE PATIENT
• Common Device Name: PHASITRON BREATHING CIRCUIT
• 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: 20598366
• Report Number: 3029845-2024-00046
• Device Sequence Number: 6558751
• Product Code: NHJ
• UDI-Device Identifier: 00849436000334
• UDI-Public: 00849436000334
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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 Model Number: A50605-D
• Device Catalogue Number: A50605-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/04/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1000524541-12/15/2023-00
• Patient Sequence Number: 1
• Patient Sex: Unknown