MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYNTUS BODY PC; PLETHYSMOGRAPH, VOLUME

Model Number	VYNTUS BODY PC
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information about the incident is not comprehensible.The customer was asked to assist with understanding the incident but has not answered to date.The risk will be evaluated as soon as further information are available and a follow up report will be submitted.
Event or Problem Description
Vyaire was informed on the 20-may-2024 by the fda that the customer reported this incident under the reference number (b)(4).The customer reported the following: "software malfunctioned on our vyaire vyntus body box in lab and could not get spirometry testing screen to pull up.Test is strictly timed, so threw off testing accuracy and led to medication needing to be administered again once glitch was fixed before we could continue.Software upgrade needed as soon as possible.Different problems continue to present themselves on different parts of testing on a more and more frequent basis.".
Additional Manufacturer Narrative
The information about the incident is not comprehensible.The customer was asked to assist with understanding the incident but has not answered to date.The risk will be evaluated as soon as further information are available and a follow up report will be submitted.
Event or Problem Description
This report was due on 20-jul-2024, but was submitted late due to an software error.This was noticed after receiving the denied acknowledgement and the date of this report was changed to the 11-jul-2024.Vyaire was informed on the 20-may-2024 by the fda that the customer reported this incident under the reference number (b)(4).The customer reported the following: "software malfunctioned on our vyaire vyntus body box in lab, and could not get spirometry testing screen to pull up.Test is strictly timed, so threw off testing accuracy and led to medication needing to be administered again once glitch was fixed before we could continue.Software upgrade needed as soon as possible.Different problems continue to present themselves on different parts of testing on a more and more frequent basis.".

• Brand Name: VYNTUS BODY PC
• Common Device Name: PLETHYSMOGRAPH, VOLUME
• 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: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204 ; 2402760001
• MDR Report Key: 19663740
• Report Number: 9615102-2024-00151
• Device Sequence Number: 17777125
• Product Code: JEH
• UDI-Device Identifier: 04250892904689
• UDI-Public: (01)04250892904689
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K190853
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: VYNTUS BODY PC
• Device Catalogue Number: 31797-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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