MAUDE Adverse Event Report: PERCUSSIONAIRE IPV 2C; NONCONTINUOUS VENTILATOR

Model Number	K00002-C
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported due to a patient experiencing a pneumothorax and pneumomediastinum after using percussionaire's ipv 2c device.The device was sent back to sentec for internal assessment.After undergoing functional testing, the product was confirmed to be performing as intended.As the scenario of inconsistent pressure could not be replicated by the service department and the product was functioning as intended, this event is being concluded as a user induced issue.At the time of this mdr, no additional information has been provided on patient status.A follow up mdr will be submitted if any additional information is received.
Event or Problem Description
On (b)(6) 2024, percussionaire was notified that while a patient was being treated with the ipv 2c therapy device, the patient experienced bradycardia.Treatment was stopped immediately and the patient was placed on a ventilator.An immediate x-ray was taken on the patient and it as discovered that the patient experienced a large pneumothorax and pneumomediastinum.The customer inspected the unit off the patient and the ipv 2c displayed a series of error codes.When the customer tested the device with a new breathing circuit, the device would not generate consistent pressure.

• Brand Name: IPV 2C
• Common Device Name: NONCONTINUOUS VENTILATOR
• 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: 19532462
• Report Number: 3029845-2024-00036
• Device Sequence Number: 20759350
• Product Code: NHJ
• UDI-Device Identifier: 00849436000037
• UDI-Public: 00849436000037
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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: K00002-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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