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	Laceration(s) (1946)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire that after a plethysmography measurement, a male patient became dizzy and fell out of the box.It resulted in a minor injury of laceration on the forehead.The patient was precautionary taken to the emergency department in the hospital the incident occurred to treat his laceration on the forehead.
Additional Manufacturer Narrative
During the investigation, it was determined that the patient has a pertinent reported medical history of hypertension, hyperlipidemia, and tias.The adverse event happened due to the patient's condition and pre-existing medical history and it resulted in a minor injury.The patient was taken to the er where the wound was cleaned and closed with skin adhesive and the patient was diagnosed with syncope and discharged.The device marketed by vyaire did not malfunction.As the adverse event happened in a hospital and the minor injury was treated there, this complaint is proactively reported to the fda and is not seen as a serious injury.

• 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: 18090437
• Report Number: 9615102-2023-00144
• Device Sequence Number: 5992938
• Product Code: BZC
• UDI-Device Identifier: 04250892904689
• UDI-Public: (01)04250892904689(11)220926
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

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: 09/14/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male