MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYNTUS ONE-PFT PC 5PR; CALCULATOR, PULMONARY FUNCTION DATA

Model Number VYNTUS ONE PFT

Device Problem Mechanical Problem (1384)

Patient Problem Dyspnea (1816)

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported to vyaire medical that the patient was having difficulty taking a breath in during dlco, it was almost like a stuttering or there was a "pop off" happening.Module was replaced back in february.The user stated that the patient seem to have a more difficult time breathing and taking the breath in on this unit vs the body box.

Manufacturer Narrative

A vyaire field service representative(fsr) evaluated the device onsite and observed chatter of dlco (diffusing capacity for carbon monoxide)proprtional valves during inspiration.The fsr ran dlco evalve andran offset on o2 evalve for the frc (functional residual capacity) test.The dlco inspire improved but still getting a less pronounced pop with the initial valve opening.The sensation is like a build of negative pressure of inspire and the valve will pop open.The edemand valve assembly was replaced and the issue was resolved.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VYNTUS ONE-PFT PC 5PR
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97201 ; GM 97201
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15611749
• MDR Text Key: 302963584
• Report Number: 9615102-2022-00130
• Device Sequence Number: 1
• Product Code: BZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181524
• 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
• Type of Report: Initial
• Report Date: 09/21/2022

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
• Device Operator: Health Professional
• Device Model Number: VYNTUS ONE PFT
• Device Catalogue Number: V-178602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2020
• 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