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

Model Number VYNTUS APS

Device Problem Computer Software Problem (1112)

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

Event Date 07/06/2022

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 3.20.1 software of the vyntus aps incorrectly interprets this as "mild" positive on the severity indicator bar for airway hyperresponsiveness.As such, the software glitch led to patients being misdiagnosed with mild asthma, and one of these patients was started on treatment.However, no allegation of harm has been reported.

Manufacturer Narrative

The customer removed the severity indicator bar graphic from the report printouts as a temporary fix.At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

Manufacturer Narrative

"the investigation resulted in a bug within the ses 3.20 that showed an incorrect classification bar on methacholine report.A risk assessment was performed and resulted in a medium health risk.Therefore, capa-000001053 was initiated.The issue is addressed in a patch for sentrysuite version 3.20.No trends identified.Two complaints were registered regarding this issue until now." device not available for evaluation, not necessary as it was a software bug.Updated the failure codes with imdrf code references.

• Brand Name: PRODUCT VYNTUS APS
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97204 ; GM 97204
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97204 ; GM 97204
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618
• MDR Report Key: 15557726
• MDR Text Key: 304358124
• Report Number: 9615102-2022-00129
• Device Sequence Number: 1
• Product Code: BZC
• 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: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

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 APS
• Device Catalogue Number: V-146405
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: No
• 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