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

Model Number	V-378510
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that on the methacholine challenge test reports, that if the result is negative but the pd20 is reached in the "normal" range, the sentrysuite 3.20.3 software of the vyntus aps incorrectly interprets this as "mild" positive on the severity indicator bar for airway hyperresponsiveness.Displayed measurement results on the report are correct.No harm to the patient was reported.
Additional Manufacturer Narrative
During further investigation regarding the manufacturer report #9615102-2022-00129, it was discovered that this second complaint with a similar issue was registered.The risk regarding this complaint was initially not recognized, therefore it will be reported now.The investigation resulted in a bug within the software ses 3.20 that showed an incorrect classification bar on methacholine report.A risk assessment resulted in a medium health risk.Therefore, a capa was initiated.The issue is addressed in a patch for sentrysuite version 3.20 which has already been released.No further adverse event registered.H3 other text : software issue.

• Brand Name: VYNTUS
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg ; GM
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg ; GM
• MDR Report Key: 17650879
• Report Number: 9615102-2023-00136
• Device Sequence Number: 6457324
• Product Code: BZC
• UDI-Device Identifier: 04250892904863
• UDI-Public: (01)04250892904863(11)211014
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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-378510
• Device Catalogue Number: V-378510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2021
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male