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

Model Number	A50605-D
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This incident is being re-evaluated as part of newly implemented procedures.Due to the patient experiencing a drop in oxygen levels while using the phasitron device, this incident is deemed reportable.The user stated the phasitron was not generating enough pressure and therefore, the patient experienced a drop in oxygen while transferring to another option.The phasitron was received back and investigated internally with the same parent device.It was determined through testing that the phasitron device does not work efficiently and as intended if not attached to the parent device correctly.It can be assumed that the end user attached the phasitron incorrectly, and therefore, the device failed to perform as intended.The instructions for use details how to attach the phasitron to the parent device.At this time no additional information has been provided on the patient or incident.If any additional information is received, a follow up mdr will be filed.
Event or Problem Description
Per the complaint, enough pressure was unable to be generated through the phasitron device.The patient experienced mild desat (drop in oxygen levels) when the customer was attempting to transition to another phasitron.

• 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: 18573267
• Report Number: 3029845-2024-00009
• Device Sequence Number: 12725844
• Product Code: CBK
• UDI-Device Identifier: 00849436000334
• UDI-Public: 00849436000334
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: A50605-D
• Device Lot Number: WO04373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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