MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. IPV-2C; INTRAPULMONARY PERCUSSIVE VENTILATION,

Model Number F00002-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 02/06/2020

Event Type  Injury  

Event Description

A complaint was received by the customer stating a patient experienced pneumothorax after using the ipv device.This was stated to be discovered via x-ray.It was later confirmed by the site that the device did not cause the patient pneumothorax.An investigation was still conducted accordingly.

Manufacturer Narrative

This incident is being re-evaluated as part of newly implemented procedures.Due to the customer initially stating the patient experienced pneumothorax after using the ipv device, this incident is deemed reportable.The site completed their own internal investigation and through additional x-rays of the patient taken post ipv therapy, it was determined that the ipv device did not actually cause the patient pneumothorax.The site contact stated that after the ipv use, an x-ray was completed, confirming no pneumothorax was present.The pneumothorax presented itself some time later that day, again via x-ray, well after the device had been used initially.Percussionaire received the device back for internal investigation.The device passed all functional tests and was noted to be performing as intended.It has been determined that the device did not cause patient pneumothorax at this time.No additional information has been received on patient status.If any additional information is received for this incident, a follow up mdr will be filed.

• Brand Name: IPV-2C
• Type of Device: INTRAPULMONARY PERCUSSIVE VENTILATION,
• 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: 18573159
• MDR Text Key: 333622935
• Report Number: 3029845-2024-00008
• Device Sequence Number: 1
• Product Code: NHJ
• UDI-Device Identifier: 00849436000037
• UDI-Public: 00849436000037
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F00002-C
• Device Catalogue Number: S00003-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1