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

Model Number V-378510

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 322287677
• Report Number: 9615102-2023-00136
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 04250892904863
• UDI-Public: (01)04250892904863(11)211014
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: V-378510
• Device Catalogue Number: V-378510
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2021
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male