MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYNTUS ONE US; CALCULATOR, PULMONARY FUNCTION DATA

Model Number	V-178600-13
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A vyaire field service representative (fsr) evaluated the device onsite and observed chatter of dlco (diffusing capacity for carbon monoxide) proportional valves during inspiration.The fsr ran the dlco offset adjustment of the e-valve and performed the offset adjustment on the o2 e-valve for the frc (functional residual capacity) test.The dlco inspiration was improved but was still getting a less pronounced pop with the initial valve opening.The sensation is like a build of negative pressure during inspiration and the valve will pop open.The edemand valve assembly was replaced and the issue was resolved.The root cause of the investigation was handled in a capa.It concluded that the fluttering is not a clinical or patient safety issue rather a nuisance from a user perspective, but not one that significantly impacts the measurement.The new firmware will be release with the next maintenance package 8 for ses 3.20 as a performance enhancement that does not mitigate risk as no new risk was identified.Therefore, the complaint could be confirmed, however a final root cause could not be determined.
Event or Problem Description
This is a supplemental report to the already existing initial report with mfr report#: 9615102-2022-00130.Due to a software change it is not possible to refer to the old complaint, so this is incorrectly marked as an initial report.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.

• Brand Name: VYNTUS ONE US
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97201 ; GM 97201
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204 ; 2402760001
• MDR Report Key: 21620678
• Report Number: 9615102-2025-00164
• Device Sequence Number: 8510196
• Product Code: BZC
• UDI-Device Identifier: 04250892904733
• UDI-Public: (01)04250892904733(11)200213
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K181524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: V-178600-13
• Device Catalogue Number: V-178600-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown