MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. TRANSPORT PHASITRON; VENTILATOR

Model Number	A50605-D
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per customer complaint, a new phasitron circuit was set up, ready to be used but would not generate a pulsatile flow or frequency consistently.No patient injury or harm was reported.
Additional Manufacturer Narrative
This incident is deemed reportable, as the phasitron circuit failed to perform properly, providing proper flow and frequency, while in use with a ventilator on a patient.The device was sent back to percussionaire for evaluation.The situation could not be replicated, and therefore no root cause could be determined.No patient harm or injury has been reported at this time.If additional information on this incident becomes available, a follow up mdr will be filed.

• Brand Name: TRANSPORT PHASITRON
• Common Device Name: VENTILATOR
• 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: 18573322
• Report Number: 3029845-2024-00010
• Device Sequence Number: 7923668
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A50605-D
• Device Lot Number: WO04755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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