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

Model Number	V-178500-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After further analysis, it was determined that the patient has a reported medical history.The patient was being evaluated for a heart transplantation.The adverse event happened due to the patient's condition and pre-existing medical history and it resulted in a serious injury.The patient was taken to the er where a mri was performed.The patient was discharged the next day with a subdural hematoma.The device marketed by vyaire did not malfunction and there is no indication that it contributed to the incident.
Event or Problem Description
It was reported to vyaire that a female patient suffered a seizure while sitting inside the vyntus body and resulted in hitting her head on the glass wall.The patient was taken to the emergency room because she suffered a subdural hematoma.The incident occurred in between measurements.The device did not malfunction.The patient was discharged from the hospital the next day.

• Brand Name: VYAIRE
• Common Device Name: 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: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 18158351
• Report Number: 9615102-2023-00145
• Device Sequence Number: 20828754
• Product Code: BZC
• UDI-Device Identifier: 04250892904689
• UDI-Public: (01)04250892904689(11)221129
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: V-178500-13
• Device Catalogue Number: V-178500-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female