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

Model Number F00002-C

Device Problem Output Problem (3005)

Patient Problems Bradycardia (1751); Pneumothorax (2012); Low Oxygen Saturation (2477)

Event Date 11/03/2023

Event Type  Injury  

Manufacturer Narrative

Due to the patient experiencing bradycardia, desaturation and bilateral tension pneumothorax after using the ipv device, this mdr is being filed.Upon becoming aware of this adverse event, a percussionaire repsresentative visited the customer site to evaluate the system.The representative visited the site november 20th and completed a full functional test on the device, and confirmed it to be working appropriatley.Currently root cause is still being determined.As the device passed all funcitonal requirements, potential cause likely user error or other specific site factors not known by percussioniare.Percussionaire intends to complete a formal evaluation on the device and is waiting for the device to be sent back.No additional information has been received on patient status.A follow up mdr will be filed once a difinitive root cause is determined.

Event Description

Per customer feedback, while performing ipv therapy on a patient, the frequency had stopped and a loud rush of pressure was heard from the device.The patient was removed from the device.A system failure error code appeared on the device, prompting the customer to contact the manufacturer.The patient subsequently developed bradycardia and desaturation.Additional medical intervention was required to stabalize the patient.Once stabalized, the patient received a chest x-ray which showed bilateral tension pneumothorax.

• 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: 18573492
• MDR Text Key: 333625786
• Report Number: 3029845-2024-00016
• 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: Inspection
• 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?: Yes
• Device Model Number: F00002-C
• Device Catalogue Number: S00003-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 7 WK